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Endoscopic bariatric therapies (EBTs) are emerging as nonsurgical weight loss interventions that are being used with increasing frequency. Similar to the potential for early and late complications from bariatric surgeries, metabolic derangements and nutritional deficiencies can also be seen after EBTs. In particular, thiamine deficiency is a well-known complication typically presenting with neurological symptoms, commonly Wernicke encephalopathy or dry beriberi. However, such a deficiency developing after placement of a temporary device such as an intragastric balloon is not only unique, but the clinical presentation of isolated ascending sensory neuropathy is very rare, both of which were seen in our patient.

The prevalence of obesity continues to rise, and along with it comes a multitude of health-related consequences. The healthcare community has consistently struggled with providing treatment options to obese patients, in part due to the reluctance of patients in pursuing the more effective (yet invasive) surgical approaches such as sleeve gastrectomy and Rou-en-Y gastric bypass. On the other hand, the less invasive approach such as lifestyle/behavioral interventions and pharmacotherapy (Orlistat, Phenteramine, Phentermine/Topiramate, Locaserin, Naltrexon/Buproprion, and Liraglutide) have very limited efficacy, especially in the morbidly obese patients. Despite our best efforts, the epidemic of obesity continues to rise and pose enormous costs on our healthcare system and society. Bariatric endoscopy is an evolving field generated to combat this epidemic through minimally invasive techniques. These procedures can be performed in an ambulatory setting, are potentially reversible, repeatable, and pose less complications than their invasive surgical counterparts. These modalities are designed to alter gut metabolism by means of space occupation, malabsorption, or restriction. In this review we will discuss different bariatric endoscopic options (such as intragastric balloons, endoscopic sleeve gastroplasty, endoscopic aspiration therapies and gastrointestinal bypass sleeves), their advantages and disadvantages, and suggest a new paradigm where providers may start incorporating this modality in their treatment approach for obese patients., Competing Interests: Conflict-of-interest statement: The authors of this manuscript have no conflicts of interest.

Introduction: The use of intragastric balloons (IGB) for the treatment of obesity has been increasing significantly, with data confirming its effectiveness with low complication rates. Adjustable balloons are not widely available for use in all countries, including the USA. In this video, we demonstrate a unique technique in which a conventional nonadjustable balloon is modified to an adjustable balloon to improve weight loss., Methods: A 35-year-old woman with a BMI of 36.1 kg/m 2 (84.4 kg) who had failed prior medical therapy for obesity presented for IGB placement. After discussion with the patient, including risks and benefits, a conventional IGB modified to a novel adjustable IGB was placed., Results: In this primary experience, we describe the use of a conventional IGB modified to an adjustable balloon. First, during balloon placement, an initial 500 ml of saline was instilled. At one-month follow-up, the patient only experienced 3.67%TBWL; thus, the balloon was adjusted with the addition of 160 ml of saline through the newly created modification catheter. At a 2-month follow-up, a second adjustment was performed with the addition of 180 ml, for a total of 840 ml. At 4 months, patient experienced 10% TBWL and decreased in BMI by 3.6 kg/m 2 . No adverse events were reported., Conclusion: The transformation of a nonadjustable balloon into an adjustable balloon is feasible and effective in weight loss. This technique may be an alternative in cases where adjustable balloon is not available. Further studies are warranted to confirm the safety and efficacy of this novel device.

Purpose of Review: In this review, we describe the FDA-approved and investigational devices and endoscopic bariatric therapies for the treatment of obesity. We focus on literature published in the past few years and present mechanisms of action as well as efficacy and safety data., Recent Findings: Devices and endoscopic procedures are emerging options to fill the significant treatment gap in the management of obesity. Not only are these devices and procedures minimally invasive and reversible, but they are potentially more effective than antiobesity medications, often safer for poor surgical candidates and possibly less expensive than bariatric surgery. As many patients require a variety of management strategies (medications, devices, procedures, and/or surgery) in addition to lifestyle modifications to achieve clinically significant weight loss, the future of obesity treatment involves a multidisciplinary approach. Combinations of advanced treatment strategies can lead to additive or synergistic weight loss. This is an area that requires further investigation.

Obesity is a public health epidemic associated with a number of comorbidities, most notably type 2 diabetes and hypertension, as well as elevated all-cause mortality. The treatment for obesity and its associated comorbidities has most recently expanded into the field of bariatric endoscopy. This field bridges a gap between lifestyle counseling with or without pharmaceutical treatment and the most effective treatment of obesity, bariatric surgery. Because of its minimally invasive nature, bariatric endoscopic therapy has the potential to appeal to the large sector of the obese population that resists surgery, as well as those early in the onset of obesity. To date, five endoscopic devices have been approved by the U.S. Food and Drug Administration for the treatment of obesity, and many more are in development, undergoing clinical trials, or being used around the world. Here, we present the current state of the field, highlight recent developments, and describe the clinical outcomes of these minimally invasive procedures in terms of weight loss, improvement in metabolic profile, and reduction in comorbidities., (© 2017 New York Academy of Sciences.)

Obesity remains a tremendous public health, clinical, and scientific challenge globally. Conventional approaches in the management of obesity offer limited potential for sustained weight loss. Bariatric surgery, although it represents the most effective weight loss treatment, has its own risks and is associated with substantial costs and limited patient applicability. Endoscopic weight loss procedures are considered as the major breakthrough in the management of obesity. Endoluminal interventions performed entirely through the gastrointestinal tract have evolved as a result of an attempt to replicate some of the anatomical features and the physiological effects of the traditional weight loss surgery while being reversible, less invasive, and more cost-effective. Restrictive procedures act to decrease gastric volume by space-occupying devices and/or by suturing or stapling techniques that alter gastric anatomy, whereas malabsorptive procedures tend to create malabsorption by preventing food contact with the duodenum and proximal jejunum. Other procedures act by influencing gastric function (gastric botulinum injections, gastric pacing, and vagal nerve blocking) or by gastric aspiration. It is important to underline that the majority of endoscopic weight loss procedures are still being evaluated and are not yet available routinely. Even though some of the techniques and devices that have recently emerged have demonstrated promising short-term results, evidence on their safety and long-term efficacy from well-designed and well-conducted research should be given before they can become an inherent part of everyday clinical practice. Given the rapid development of endoscopic weight loss procedures, this review considers the current state and recent trends in endoscopic management of obesity., (© The Author(s) 2016.)

BACKGROUND: Obesity is a major threat to public health and traditional bariatric surgery continues to have low utilization. Endoscopic treatments for obesity have emerged that offer less risk, but questions remain regarding efficacy, durability, and safety. We compared the efficacy of endoscopic bariatric procedures as compared to other existing treatments. METHODS: A literature search of Embase, Cochrane Central, and Pubmed was conducted from January 1, 2014 to December 7, 2021, including endoscopic bariatric therapies that were FDA or CE approved at the time of search to non-endoscopic treatments. Thirty-seven studies involving 15,639 patients were included. Primary outcomes included % total body weight loss (%TBWL), % excess body weight loss (%EBWL), and adverse events. Secondary outcomes included quality of life data and differences in hemoglobin A1C levels. Strength of clinical trial and observational data were graded according to the Cochrane methods. RESULTS: Intragastric balloons achieved greater %TBWL with a range of 7.6-14.1% compared to 3.3-6.7% with lifestyle modification at 6 months, and 7.5-14.0% compared to 3.1-7.9%, respectively, at 12 months. When endoscopic sleeve gastroplasty (ESG) was compared to laparoscopic sleeve gastrectomy (LSG), ESG had less %TBWL at 4.7-14.4% compared to 18.8-26.5% after LSG at 6 months, and 4.5-18.6% as compared to 28.4-29.3%, respectively, at 12 months. For the AspireAssist, there was greater %TBWL with aspiration therapy compared to lifestyle modification at 12 months, 12.1-18.3% TBWL versus 3.5-5.9% TBWL, respectively. All endoscopic interventions had higher adverse events rates compared to lifestyle modification. CONCLUSION: This review is the first to evaluate various endoscopic bariatric therapies using only RCTs and observational studies for evaluation of weight loss compared with conservative management, lifestyle modification, and bariatric surgery. Endoscopic therapies result in greater weight loss compared to lifestyle modification, but not as much as bariatric surgery. Endoscopic therapies may be beneficial as an alternative to bariatric surgery.

Introduction: The intragastric balloon is a medical device inserted into the stomach endoscopically and filled with either air or more commonly, saline. Widely utilised since the 1980s, numerous studies have affirmed its safety and effectiveness as a temporary treatment for weight loss. Despite this, there have been reports of rare but severe complications associated with its usage. Case description: We report the case of a 33-year-old female presented with two-day history of epigastric pain, nausea and vomiting. This occurred after having a gastric balloon placed endoscopically two months earlier. A contrast-enhanced abdominal CT scan revealed a partially deflated and migrated intragastric balloon in the proximal jejunum, causing intestinal obstruction without any signs of bowel perforation. The diagnosis was established as intestinal obstruction due to the migrated intragastric balloon. An emergency endoscopic procedure was undertaken, successfully removing the balloon thus highlighting a unique attempt to endoscopically retrieve a migrated intragastric balloon from the jejunum. Conclusion: The efficacy of an intragastric balloon in reducing weight in a short time is gaining more popularity. The more common it becomes the more we must be vigilant about its complications. We advise regular follow-up of patients and emphasise patient education of possible signs and symptoms of intragastric balloon migration, which will avoid serious complications.

A 32-year-old female patient presented to the emergency department with vomiting twice and then severe pain in the retrosternal region. After excluding cardiac emergencies, it was decided to perform an emergency endoscopy on the patient. A foreign body that completely occludes the lumen and does not allow the passage of the gastroscope was observed at the 30th cm of the esophagus from the incisors. The foreign body was determined to be intragastric balloon (IGB). The balloon was punctured in many places with a sclerotherapy needle and completely evacuated. The balloon was then grasped with forceps and removed. The patient was discharged after 1 night of hospitalization. Although IGB treatment is a safe practice, it may rarely lead to complications. Complications may result from operator or user error. If both the practitioner and the patient can fulfill their responsibilities properly, complications can be prevented and treatment success can be increased. [ABSTRACT FROM AUTHOR]

Obesity is becoming increasingly prevalent worldwide, and its metabolic sequelae lead to a significant burden on healthcare resources. Options for the management of obesity include lifestyle modification, pharmacological treatment, surgery, and endoscopic bariatric therapies (EBTs). Among these, EBTs are more effective than diet and lifestyle modification and are less invasive than bariatric surgery. In recent years, there have been significant advances in technologies pertaining to EBTs. Of all the available EBTs, there is a significant amount of clinical experience and published data regarding intragastric balloons (IGBs) because of their comparatively long development period. Currently, the United States Food and Drug Administration (FDA) has approved three IGBs, including Orbera (Apollo Endosurgery, Austin, TX, USA), ReShape Duo (ReShape Medical, San Clemente, CA, USA), and Obalon (Obalon Therapeutics, Carlsbad, CA, USA). The aim of this review is to summarize the available literature on the efficacy of IGBs in weight loss and their impact on obesity-related metabolic diseases.

Abstract Background Obesity is a global problem leading to reduced life expectancy, cardiovascular diseases, diabetes and many types of cancer. Even people willing to accept treatment only achieve a mean weight loss of about 5 kg using commercial weight loss programs. Surgical interventions, e.g. sleeve gastrectomy or gastric bypass are effective but accompanied by risk of serious complications and side effects. Less invasive endoscopic procedures mainly comprise the intragastric balloon (IB) and the duodenal-jejunal bypass liner (DJBL). To date, a randomized comparison between these devices has not been undertaken or shown to be superior to a sham procedure. Methods We designed a multi-center, randomized, patient and assessor-blinded, controlled trial comparing weight loss in endoscopically implanted IB vs. DJBL vs. a sham procedure. A total of 150 patients with a BMI > 35 kg/m2 or > 30 with obesity-related comorbidities and indication for proton pump inhibitors are randomized to receive either IB, DJBL or a sham gastroscopy (2:2:1 ratio). All participants undergo regular dietary consultation. The IB will be removed after 6 months, whereas the DJBL will be explanted after 12 months. All patients will receive gastroscopies at implantation and explantation of the devices or sedation without gastroscopy to maintain blinding. Main exclusion criteria are malignant diseases, peptic ulcer or previous bariatric intervention. Weight loss 12 months after explantation of the devices, changes in comorbidities, quality of life, complication rates and safety will be evaluated. Discussion This trial could help to identify the most effective and safest endoscopic device, thus determining the new standard procedure for endoscopic bariatric treatment. Trial registration 16th January 2017. DRKS00011036. Funded by the German Research Foundation (DFG).

Background: The effect of age, gender, and baseline BMI as predictors of weight loss outcome in patients undergoing bariatric surgery is controversial with conflicting results in the surgical literature. Few studies evaluated the effect of age, gender, and baseline BMI on weight loss in patients undergoing the intragastric balloon (IGB). This study aimed to evaluate age and gender and baseline BMI as predictors of weight loss in a group of obese patients who were treated with the IGB. Methods: We prospectively followed 229 patients who underwent the Orbera IGB in the period between June 2014 and December 2017, performed at one institution. Data were collected for age, gender, baseline weight, and baseline BMI. At 6 months of IGB insertion, the following parameters were documented: % excess weight loss (%EWL), total body weight loss (TBWL), and % total body weight loss (%TBWL). Patients were categorized according to gender and age groups: age less than 40 years and age equal to or more than 50 years (45 patients who were 40–49 years old were excluded). Baseline BMI was grouped into 2 groups: BMI < 35 and BMI > 40. Patients in the BMI range of 35–40 were excluded. Linear regression analysis was used to evaluate the effect of age, gender, and baseline BMI on weight loss. T test was used to compare the means of TBWL, %EWL, and %TBWL between the groups studied. Results: One hundred eighty-four patients (80% female) were enrolled in the study; 135 (106 females and 29 males) younger than 40 years, and 49 (42 females and 7 males) with age equal or more than 50 years. There was a significant effect of age on weight loss in females at 6 months, with more weight loss (as measured by % excess weight loss) in the younger age group compared with patients aged 50 years or more (% excess weight loss was 47.34% and 38%, respectively, p value = 0.04). There was no difference in % excess weight loss in the younger or older male patients (% excess weight loss was 50.21% and 47.05%, respectively, p value = 0.836). Patients of both sexes with lower baseline BMI had a significantly more % excess weight loss compared with the group with the higher baseline BMI (%EWL females/males 53.7%/50.1% and 32.5%/32.2%, respectively, p value <0.01). Conclusions: Female patients younger than 40 years lost greater amount of excess weight than older patients at 6 months after IGB insertion. On the other hand, age did not alter the outcome in male patients. Lower baseline BMI was significantly correlated with greater excess weight loss in both sexes. Age and baseline BMI can be used as predictors of weight loss outcome in patients treated with IGB. [ABSTRACT FROM AUTHOR]

Background: Obesity and its metabolic sequelae are among the most serious challenges faced by health systems today and they are expected to pose a serious threat in the future as well. Therapy ranges from lifestyle modification to drug treatment to surgery. Metabolic endoscopy (ME) might close the gap between invasive "metabolic" surgery and conservative, less effective treatment. In recent years, several endoscopic approaches have emerged, promising a safe and effective approach to cope with obesity. Data on metabolic endpoints is scarce. This article will therefore highlight procedures with data on type 2 diabetes mellitus (T2DM) as the most prominent component of the metabolic syndrome. Summary: Most procedures showed beneficial effects in terms of weight reduction. For gastric procedures, there were no systematic studies primarily addressing parameters of glucose metabolism or diabetes outcomes. Metabolic benefit, if there is any, is most likely a by-product of weight loss. By contrast, duodenal-jejunal bypass sleeve (DJBS) is conceptually an antidiabetic procedure. Although adverse events are frequent, recent data points to a positive benefit-risk ratio. Key Messages: ME has the potential to constitute a growing field in the treatment of obesity and associated T2DM. While data published on glycaemic parameters in restrictive approaches is not sufficient, there is strong evidence that malabsorptive DJBS has an antidiabetic "plus" effect. Further studies are necessary to define the role of ME within a lifelong concept of treating obesity and T2DM. [ABSTRACT FROM AUTHOR]

Background: Obesity is a growing global epidemic with tremendous financial burden and health care costs worldwide. Restrictive surgery has emerged as the definitive treatment option to combat morbid obesity and its associated comorbidities. The advent of endoscopy has new grounds in obesity with the introduction of inflatable balloon placed in the stomach that decreases satiety by volume restriction.Materials and Methods: We report a first case of gastric perforation with peritonitis after ReShape intragastric balloon placement that needed emergent surgical intervention. Decision was made to proceed with exploratory laparotomy, device deflation, and removal with subsequent gastric defect repair.Results: Postoperative period was uneventful, drain was removed on postoperative day 2, and patient tolerated diet and was discharged home subsequently. Biopsy of the perforation site demonstrated mild non-specific chronic gastritis.Conclusion: In the modern era of minimal invasiveness, any new approach would roar popularity among patients and hence is of utmost importance for clinicians to be constantly educated on scientific research and innovations in their field. [ABSTRACT FROM AUTHOR]

Obesity is considered the most common nutritional disorder in Western countries and is related to multiple morbidity and mortality. There are different options for obesity treatment, including diet, behavioral therapy, medications, and surgery. If patients do not meet the criteria for bariatric surgery, intragastric balloons may be used to achieve weight reduction. Currently, the intragastric balloon is one of the most common bariatric procedures in obese patients in Europe. Gastric perforation associated with intragastric balloon is a rare but dangerous complication. We report a case of a 42-year-old female patient who presented to the emergency department with acute abdomen. Chest x-ray in an erect posture indicated free gas under the diaphragm. She had undergone placement of an intragastric adjustable balloon device 13 months earlier and was overdue for removal of the balloon. In the emergency theater, a large perforated ulcer was found in the posterior wall of the stomach, which was repaired laparoscopically. Her postoperative course was uneventful. We also review the literature on intragastric balloon–induced gastric perforation. Our case is a very rare report of late gastric perforation after adjustable intragastric balloon placement. We recommend regular follow-up and removal in proper time after insertion of the gastric balloon. [ABSTRACT FROM AUTHOR]

Background Intragastric balloons (IGBs) are a minimally invasive option for obesity treatment, acting as a space-occupying device and leading to weight loss through increased satiety. This device has been growing in popularity owing to its safety profile and good weight loss results. However, there are no published guidelines that standardize the technical aspects of the procedure. Objectives To create a practical guideline for intragastric balloon usage. Setting Private and Academic Settings, Brazil. Methods A consensus meeting was held in São Paulo, Brazil, in June 2016, bringing together 39 Brazilian endoscopists with extensive experience in IGBs from all regions of the country. Topics on patient selection, indications, contraindications, multidisciplinary follow-up, technique, and adverse events were discussed in the form of questions. After electronic voting, a consensus was defined when there was ≥70% agreement. Experts were also requested to provide data on their experience with IGBs. Results The selected experts discussed and reached a consensus on 76 questions, mainly concerning specific indications and contraindications for the procedure; technical details, such as patient preparation, minimum balloon-filling volume, techniques for implant and explant; patient follow-up and recommended medication for the adaptation period; and adverse event management. The overall Brazilian expert data encompassed 41,863 IGBs, with a mean percentage total weight loss of 18.4% ± 2.9%. The adverse event rate after the adaptation period was 2.5%, the most common being hyperinflation (.9%) and spontaneous deflation (.8%) of the device. The early removal rate due to intolerance was 2.2%. Conclusions The present consensus represents practical recommendations for performing IGB procedures and reflects Brazil’s significant experience with this device. The experience of over 40,000 cases shows that the device leads to satisfactory weight loss with a low rate of adverse events. [ABSTRACT FROM AUTHOR]

Intragastric balloons are a minimally invasive option for weight loss. They are generally well tolerated and rarely associated with serious adverse events. We report a case of major upper gastrointestinal haemorrhage after insertion of an Orbera® intragastric balloon. [ABSTRACT FROM AUTHOR]

Weight management is increasingly incorporating endoscopic bariatric therapy (EBT). As the global burden of obesity and its comorbidities has increased, it is evident that novel therapeutic approaches will be necessary to address the obesity epidemic. EBTs offer greater efficacy than diet and lifestyle modification and lower invasiveness than bariatric surgery. The US Food and Drug Administration has approved two intragastric balloons and aspiration therapy for the treatment of obesity: Apollo Orbera is indicated for the treatment of Class I and Class II obesity, Re Shape Integrated Dual Balloon system is indicated for the same range with a comorbidity, and Aspire Bariatrics AspireAssist is approved for patients with a body mass index of 35-55 kg/m2. These devices have proven safe and effective in clinical trials and are gaining commercial acceptance in the USA; the Orbera has been used extensively outside the USA for over 20 years. These devices will need to be delivered in the context of a multidisciplinary weight loss program, integrating comprehensive care of obesity. Patient selection is important, and ensuring appropriate patient expectations and understanding of alternatives such as pharmacologic therapy and surgery is essential. With several EBTs on the horizon, patients with obesity will have an even broader array of safe and effective options for weight management in the future. [ABSTRACT FROM AUTHOR]

Introduction: Overweight and obesity are ranked in the fifth place among the risk factors responsible for the greatest number of deaths in the world. Aim: To assess the effects of treatment of patients with morbid obesity using endoscopic intragastric balloon (IGB) implantation. Material and methods: Two hundred and seventy-two patients with obesity were treated using endoscopic intragastric balloon implantation. Upon analysis of the inclusion and exclusion criteria, the study covered a group of 63 patients with morbid obesity. The patients were implanted with the LexBal balloon. Reduction of excess body mass, changes to BMI values and ailments and complications divided into mild and severe were assessed. Results: Before intragastric balloon treatment, the average body mass index (BMI) value was 58.3 ±10.5 kg/m2, whereas after 6 months of treatment it decreased to 49.5 ±8.7 kg/m². The patients with postoperative BMI equal to or greater than 50.0 kg/m² reported nausea (69.7%), vomiting (51.5%), flatulence (45.5%), upper abdominal pain (36.4%) and general discomfort (424%) more frequently. Dehydration (9.1%) was also more frequent in this group, whereas frequency of occurrence of such ailments and complications as heartburn (23.3%) and oesophageal candidiasis (10.0%) was higher in the patients with postoperative BMI below 50.0 kg/m². Conclusions: Endoscopic intragastric balloon implantation is an effective and safe method of excess body mass reduction in patients with morbid obesity before a planned bariatric surgical procedure. Pre-operative excess body mass and BMI value and post-operative excess weight loss in patients with morbid obesity have no impact on frequency of occurrence of ailments and complications in IGB treatment. [ABSTRACT FROM AUTHOR]

Introducción: la implantación de un balón intragástrico (BI) por vía endoscópica asociado a una dieta hipocalórica es una alternativa en el tratamiento de la obesidad. El objetivo de nuestro estudio es evaluar su efectividad, seguridad y tolerancia. Material y métodos: se incluyen de manera prospectiva 38 pacientes sin contraindicaciones para la implantación del BI, desde marzo de 2004 hasta enero de 2007. La retirada del balón se realizó 6 meses después de la implantación. Evaluamos el peso e índice de masa corporal (IMC) tras la retirada del balón, a los 6 y 12 meses postretirada, así como la tolerancia y aparición de complicaciones durante el tratamiento. Tras la retirada del balón se realizó un cuestionario a cada paciente evaluando la percepción subjetiva al tratamiento. Resultados: después de 6 meses de tratamiento la pérdida de peso media fue de 14,10 kg (0-46) y la reducción media del IMC fue de 5,23 kg/m² (0-18). A los 12 meses postretirada del balón el 48,4% de pacientes mantiene o sigue perdiendo peso. Los síntomas precoces más frecuentes fueron náuseas (71,1%) y vómitos (57,9%), con buena respuesta a tratamiento sintomático. Presentaron complicaciones 7 pacientes (18,4%): intolerancia digestiva en 4 pacientes, requiriendo retirada precoz del balón en 3 de ellos; esofagitis moderada en 2 pacientes; y perforación gástrica complicada con shock séptico y exitus en 1 paciente. Conclusiones: 1. El balón intragástrico asociado a una dieta hipocalórica puede considerarse un tratamiento efectivo, seguro y bien tolerado para el tratamiento de pacientes con obesidad mórbida. 2. La pérdida de peso se mantiene en casi la mitad de los pacientes al año tras la retirada del balón.Introduction: the endoscopic placement of an intragastric balloon (IGB) in association with a low-calorie diet is an option for the treatment of obesity. The aim of the present study was to evaluate its effectiveness, safety, and tolerance. Material and methods: thirty-eight patients with no contraindications for IGB were included in this prospective study from March 2004 to January 2007. Balloon removal was performed 6 months later. Weight and body mass index (BMI) were evaluated after IGB removal and at 6 months and 1 year thereafter. Tolerance and complications during treatment were evaluated. Patients filled out a questionnaire to evaluate their subjective perception of treatment. Results: mean weight loss after 6 months on balloon treatment was 14.10 kg (0-46), and mean BMI reduction was 5.23 kg/m² (0-18). At 12 months after balloon removal 48.4% of patients maintained their weight loss or kept loosing weight. Most common early symptoms included nausea (71.1%) and vomiting (57.9%) with a good response to symptomatic treatment. Complications were seen in 7 patients (18.4%): digestive intolerance in 4 patients, with early removal in 3 of them; moderate esophagitis in 2 patients; and gastric perforation complicated with septic shock and death in 1 patient. Conclusions: 1. IGB in association with low-calorie diet is an effective, safe, and well tolerated treatment for morbid obese patients. 2. Almost half of patients maintained their weight loss after one year from balloon removal.

Background: Endoscopic gastric balloons have been used effectively as weight loss devices for decades, but the requirement for endoscopy and sedation poses several limitations. The goal of this pilot study was to evaluate the safety and performance of a prototype version of Elipse™, a procedureless gastric balloon. Methods: Eight patients (mean BMI = 31.0 kg/m) participated in this study. Each patient swallowed one Elipse™ balloon intended to remain in the stomach for 6 weeks, self-empty, and then pass. Each balloon was filled with 450 mL of filling fluid. Patients returned every 2 weeks for abdominal ultrasound. No specific diet or exercise plan was prescribed. Results: All eight patients successfully swallowed the device. The most common adverse events were nausea and vomiting. There were no serious adverse events, and all balloons were excreted safely. Despite not being prescribed a diet or exercise plan, all eight patients lost weight. In 6/8 patients, the balloon remained full through 6 weeks, self-emptied, and passed. In one patient, the balloon appeared partially collapsed on ultrasound after 11 days and was endoscopically punctured. One asymptomatic patient elected to have the balloon endoscopically punctured after 19 days. Both balloons passed in the stool after 4 days. In both cases, endoscopic examination of the upper GI tract showed no abnormalities. Conclusions: This pilot study demonstrates the safety and performance of Elipse™, a procedureless gastric balloon for weight loss. Future studies will test a commercial design filled to 550 mL intended to last in the stomach for at least 12 weeks. [ABSTRACT FROM AUTHOR]

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Background: Research into minimally invasive techniques is worthwhile for greater acceptance in bariatric surgery, a useful first step being to evaluate the combination of these with current procedures. We suggest that intragastric balloon (IGB) can be performed with hyaluronic acid (HA) injections at the level of the gastroesophageal junction. Methods: A submucosal restriction is created by circular injection of an absorbable material within a defined area based on endoscopic anatomy. We included 101 patients in a prospective multicenter randomized trial, with average body mass index (BMI) 33.4 (range 27-44), treated from April 2010 to April 2012 by IGB and/or HA injection, sequentially, and followed for two more years. Patients were divided into group 1 (IGB alone), group 2 (IGB followed by HA at IGB removal, at 6 months), and group 3 (HA and IGB at 6 months). Results: BMI loss at 6 months was inferior in the HA group (32 patients) compared with the IGB groups (68 patients) (2.1 ± 0.4 versus 3.4 ± 0.3, p < 0.05). The efficacy of IGB alone compared with combined treatments (groups 2 and 3) was significantly inferior at 18 months only, but the impact of the treatment sequence (HA before or after IGB) on BMI loss was not statistically significant, although in favor of HA first. Conclusions: This study did not demonstrate the efficacy of HA injections as an obesity treatment. [ABSTRACT FROM AUTHOR]