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High-intensity focused ultrasound (HIFU) provides a potentially non-invasive alternative to conventional therapies. We have been using the extracorporeal ultrasound-guided Model-JC Tumor Therapy System (HAIFU™ Technology Co, China) in clinical trials to evaluate the safety and feasibility of treating renal and liver tumours. 30 patients have been treated (22 liver and 8 kidney tumours), all of whom were available for adverse event reporting. Of the 22 liver tumours, 20 are evaluable for response to treatment; 14 were followed up with magnetic resonance imaging (MRI) alone, and 6 with both MRI and histological resection. Evidence of ablation was seen in 20/20 (100%) cases radiologically, and 6/6 (100%) cases histologically. Of the 8 kidney tumours treated, 7 are evaluable; 2 were followed up with MRI alone, and 5 with both MRI and histological resection. Evidence of ablation was seen in 4/7 (57%) radiologically and 1/5 (20%) histologically. Mild, moderate or severe transient pain was reported by 16 (53%), 7 (23%) and 1 (3%) patients, respectively. Superficial skin toxicity was seen in 7 patients (23%). Renal function was unaffected, and all patients were fit for discharge from hospital the day after treatment. Early results show that this technique is feasible, and carries a low morbidity. © 2005 American Institute of Physics [ABSTRACT FROM AUTHOR]