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Transoral Gastroplasty for the Treatment of Morbid Obesity

NCT00661245 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 275

Last updated 2009-05-05

No results posted yet for this study

Summary

The TOGA® trial is a prospective, multi-center, randomized sham-controlled trial designed to determine the safety and effectiveness of the TOGA System for the treatment of morbid obesity. The study will also determine the effect of the treatment on co-morbidities and quality of life.

Subjects will be blinded to treatment or sham. Sham arm may crossover to TOGA treatment at 12 months.

Conditions

Interventions

DEVICE

TOGA

Transoral Gastroplasty (TOGA®) System for gastric stapling.

DEVICE

Control

The control device (bougie dilator) is a FDA-cleared (Class II) device.

Sponsors & Collaborators

  • Satiety, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2010-10-31

Countries

  • United States
  • Belgium

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 NCT00661245 on ClinicalTrials.gov