Endoscopic Sleeve Gastroplasty (ESG) for the Treatment of Obesity

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study is to evaluate endoscopic sleeve gastroplasty (ESG) for the treatment of obesity. The ESG procedure is an U.S. Food and Drug Administration (FDA) approved procedure for the treatment of obesity - patients with a body mass index (BMI) 30-50 kg/m2. This procedure is FDA approved; however, Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP)-Accredited centers (such as Houston Methodist Hospital) must receive approval from an Institutional Review Board (IRB) in order to perform primary procedures, such as ESG, that are not endorsed by the American Society for Metabolic and Bariatric Surgery (ASMBS).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients with BMI 30 to 50 kg/m2

• Patients that have been unable able to lose weight, or maintain weight loss, through more conservative measures (i.e., lifestyle interventions including diet and exercise) per the FDA approval for the Apollo ESG device. Lifestyle interventions may include traditional diet and anaerobic or aerobic exercise, including resistance training.

Locations
United States
Texas
Houston Methodist Hospital
RECRUITING
Houston
Houston Methodist Hospital - Sugarland
RECRUITING
Sugar Land
Contact Information
Primary
Thomas R McCarty, MD, MPH
tommccarty3@houstonmethodist.org
713-363-7436
Time Frame
Start Date: 2024-02-28
Estimated Completion Date: 2033-10
Participants
Target number of participants: 150
Treatments
Other: ESG Procedure
Endoscopic Sleeve Gastroplasty for patients with obesity using the Apollo OverStitch endoscopic suturing device.
Related Therapeutic Areas
Sponsors
Leads: The Methodist Hospital Research Institute

This content was sourced from clinicaltrials.gov