Percutaneous Gastrostomy Device for the Treatment of Class II and Class III Obesity: Results of a Randomized Controlled Trial.

ABSTRACT:

Objectives

The AspireAssist System (AspireAssist) is an endoscopic weight loss device that is comprised of an endoscopically placed percutaneous gastrostomy tube and an external device to facilitate drainage of about 30% of the calories consumed in a meal, in conjunction with lifestyle (diet and exercise) counseling.

Methods

In this 52-week clinical trial, 207 participants with a body-mass index (BMI) of 35.0-55.0 kg/m² were randomly assigned in a 2:1 ratio to treatment with AspireAssist plus Lifestyle Counseling (n=137; mean BMI was 42.2±5.1 kg/m²) or Lifestyle Counseling alone (n=70; mean BMI was 40.9±3.9 kg/m²). The co-primary end points were mean percent excess weight loss and the proportion of participants who achieved at least a 25% exc

SUBMITTER: Thompson CC 

PROVIDER: S-EPMC5350543 | biostudies-literature | 2017 Mar

REPOSITORIES: biostudies-literature