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

M. Nyström, E. Machytka, E. Norén, PA. Testoni, I. Janssen, J. Turró Homedes, JC. Espinos Perez, R. Turro Arau,

. 2018 ; 28 (7) : 1860-1868. [pub] -

Language English Country United States

Document type Journal Article, Multicenter Study, Observational Study, Research Support, Non-U.S. Gov't

Persistent link   https://www.medvik.cz/link/bmc19035421
E-resources Online Full text

NLK ProQuest Central from 1997-02-01 to 1 year ago
Medline Complete (EBSCOhost) from 2010-01-01 to 1 year ago
Health & Medicine (ProQuest) from 1997-02-01 to 1 year ago
Public Health Database (ProQuest) from 1997-02-01 to 1 year ago

Links

PubMed 29388050
DOI 10.1007/s11695-017-3096-5
Knihovny.cz E-resources

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.

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