Use of the Incisionless Operating Platform as a Primary Treatment for Obesity vs. Diet-Exercise Alone

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2013
This study is a multi-center, open/unblended study (3:1Treatment: Control) to evaluate the safety and effectiveness of the g-Cath EZ Suture Anchor Delivery Catheter as an early weight loss intervention compared to a diet and exercise control only. Mean % Total Body Weight Loss \[TBWL\] in Treatment subjects versus that of Control subjects at 12 months is the primary endpoint. The proportion of subjects achieving ≥ 5% TBWL at 12 months in the treatment group is a co-primary endpoint.
Epistemonikos ID: 2563d1751a76488f26bef24bbb3f3810a36f2c9e
First added on: May 11, 2024