Roman Turro Arau, Jesus Turró Homedes, Max Nyström, Erik Norén, Pier Alberto Testoni, Evzen Machytka, Jorge Carlos Espinos Perez, Ignace M. C. Janssen, Nyström, Max, Machytka, Evzen, Norén, Erik, Testoni, Pier Alberto, Janssen, Ignace, Turró Homedes, Jesu, Espinos Perez, Jorge Carlo, and Turro Arau, Roman
Purpose The objective of this post-market study was to evaluate long-term safety and efficacy of aspiration therapy (AT) in a clinical setting in five European clinics. Materials and Methods The AspireAssist® System (Aspire Bariatrics, Inc. King of Prussia, PA) is an endoscopic weight loss therapy utilizing a customized percutaneous endoscopic gastrostomy tube and an external device to aspirate approximately 30% of ingested calories after a meal, in conjunction with lifestyle counseling. A total of 201 participants, with body mass index (BMI) of 35.0–70.0 kg/m2, were enrolled in this study from June 2012 to December 2016. Mean baseline BMI was 43.6 ± 7.2 kg/m2. Results Mean percent total weight loss at 1, 2, 3, and 4 years, respectively, was 18.2% ± 9.4% (n/N = 155/173), 19.8% ± 11.3% (n/N = 82/114), 21.3% ± 9.6% (n/N = 24/43), and 19.2% ± 13.1% (n/N = 12/30), where n is the number of measured participants and N is the number of participants in the absence of withdrawals or lost to follow-up. Clinically significant reductions in glycated hemoglobin (HbA1C), triglycerides, and blood pressure were observed. For participants with diabetes, HbA1C decreased by 1% (P