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 < 0.0001) from 7.8% at baseline to 6.8% at 1 year. The only serious complications were buried bumpers, experienced by seven participants and resolved by removal/replacement of the A-Tube, and a single case of peritonitis, resolved with a 2-day course of intravenous antibiotics. CONCLUSION: This study establishes that aspiration therapy is a safe, effective, and durable weight loss therapy in people with classes II and III obesity in a clinical setting. TRIAL REGISTRATION: ISRCTN 49958132.

Department of Gastroenterology Ospedale San Raffaele Via Olgctnna 60 20132 Milan Italy

Department of Surgery Blekinge County Hospital Lasarettsvägen 371 85 Karlskrona Sweden

Dutch Obesity Clinics Amersfoortseweg 43 3712 BA Huis ter Heide The Netherlands

Endoscopia Digestiv Centro Medico Teknon Carrer Vilana 12 08022 Barcelona Spain

University Hospital Ostrava Pionyru 690 250 81 Nehvizdy Czech Republic

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ISRCTN
ISRCTN49958132