Dataset Information

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

ABSTRACT:

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.

SUBMITTER: Nystrom M

PROVIDER: S-EPMC6018576 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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Publications

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

Nyström Max M Machytka Evzen E Norén Erik E Testoni Pier Alberto PA Janssen Ignace I Turró Homedes Jesus J Espinos Perez Jorge Carlos JC Turro Arau Roman R

Obesity surgery 20180701 7

<h4>Purpose</h4>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.<h4>Materials and methods</h4>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 coun ...[more]

PMID: 29388050

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Dataset Information

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

Purpose

Materials and methods

Results

Conclusion

Trial registration

Publications

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

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