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The USGI Medical ESSENTIAL Study for Weight Loss

NCT01958385 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 377

Last updated 2017-04-04

No results posted yet for this study

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

Interventions

DEVICE

placement of g-Cath EZ suture anchors

PROCEDURE

Sham procedure

BEHAVIORAL

Diet and Exercise

A structured diet and exercise plan

Sponsors & Collaborators

  • USGI Medical

    lead INDUSTRY

Principal Investigators

  • Tom Lavin, MD · Crescent City Surgical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-01
Primary Completion
2015-05-01
Completion
2016-08-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01958385 on ClinicalTrials.gov