Aspiration Therapy As a Tool to Treat Obesity: 1- to 4-Year Results in a 201-Patient Multi-Center Post-Market European Registry Study

Autor: Roman Turro Arau, Jesus Turró Homedes, Max Nyström, Erik Norén, Pier Alberto Testoni, Evzen Machytka, Jorge Carlos Espinos Perez, Ignace M. C. Janssen
Přispěvatelé: Nyström, Max, Machytka, Evzen, Norén, Erik, Testoni, Pier Alberto, Janssen, Ignace, Turró Homedes, Jesu, Espinos Perez, Jorge Carlo, Turro Arau, Roman
Rok vydání: 2018
Předmět:
Zdroj: Obesity Surgery
ISSN: 1708-0428
0960-8923
DOI: 10.1007/s11695-017-3096-5
Popis: 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
Databáze: OpenAIRE