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A Feasibility Study for the Treatment of Primary Obesity

Obesity Clinical Trial

Official title:
A Feasibility Study Examining Safety and Preliminary Effectiveness of a Procedural Technique Using an Endoscopic Suturing Device and Associated Devices for the Treatment of Primary Obesity

Clinical Trial Summary

This study has been expanded to a four center, open-label, 2-group randomized pilot study evaluating a treatment for obesity.

Clinical Trial Description

This study has been expanded to a four center, open-label, 2-group randomized pilot study evaluating a treatment for obesity. The intent is to evaluate the safety and preliminary efficacy of a new Snowshoe suture placement pattern, Pose 2 (sutures placed in the mid + distal body without fundus), with a moderate intensity diet and exercise program, as compared to diet and exercise alone. The procedure will be performed using the g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors (AKA g-Cath or g-Cath EZ) and associated devices (g-Prox EZ, g-Lix and Transport), known collectively as the Incisionless Operating Platform (IOP). Efficacy will be evaluated based on changes in weight loss for all subjects through 12 months. Adverse events will be recorded throughout the duration of the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03837691
Study type Interventional
Source USGI Medical
Contact
Status Active, not recruiting
Phase N/A
Start date October 10, 2019
Completion date October 15, 2023
View Details
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