NCT01958385

The USGI Medical ESSENTIAL Study for Weight Loss

A RANDOMIZED, SUBJECT AND EVALUATOR-BLINDED, PARALLEL-GROUP, MULTICENTER CLINICAL TRIAL USING AN ENDOSCOPIC SUTURING DEVICE (G-CATH EZ™ SUTURE ANCHOR DELIVERY CATHETER) FOR PRIMARY WEIGHT LOSS

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 377 (actual)
• Sponsor: USGI Medical · Industry
• Sex: All
• Age: 22 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, evaluator and subject blinded, parallel-group, controlled study intended to evaluate the safety and efficacy of treating obese patients with the placement of g-Cath EZ suture anchors followed by a structured diet and exercise plan as compared to a sham procedure followed by the same diet and exercise plan. Subjects will be randomly assigned in a 2:1 ratio to the treatment procedure followed by diet and exercise or the sham procedure followed by diet and exercise. After un-blinding at 12 months post-treatment, sham patients can choose to have the treatment procedure as well.

Conditions

• Obesity

Interventions

Type	Name	Description
DEVICE	placement of g-Cath EZ suture anchors
PROCEDURE	Sham procedure
BEHAVIORAL	Diet and Exercise	A structured diet and exercise plan

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-05-01
• Completion: 2016-08-01
• First posted: 2013-10-09
• Last updated: 2017-04-04

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated device study