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RECRUITING
NCT06339320
NA

Endoscopic Sleeve Gastroplasty (ESG) for the Treatment of Obesity

Sponsor: The Methodist Hospital Research Institute

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2024-02-28

Completion Date

2033-10

Last Updated

2024-04-01

Healthy Volunteers

No

Interventions

PROCEDURE

Endoscopic Sleeve Gastroplasty (ESG)

The ESG procedure uses the Apollo OverStitch endoscopic suturing device, which has received FDA authorization as a minimally invasive procedure to facilitate weight loss for adults with who have been unable to lose weight or maintain weight loss through more conservative measures such as diet and exercise. This procedure involves endoscopic suturing to reduce the volume of the stomach endoscopically by approximately 70% to 80% its original size. Using the Apollo OverStitch or APOLLO ESG and ESG SX Systems, the ESG procedure is performed be folding the stomach in on itself (endoscopically) and placing full-thickness sutures through the wall of the stomach to maintain this narrow, smaller size. Following the procedure, the new stomach appears similar to the surgical sleeve stomach, although the procedure is considered less invasive with fewer complications compared to a surgical sleeve gastrectomy.

DEVICE

Apollo OverStitch endoscopic suturing device

Apollo ESG is the first and only device to be authorized by the FDA to perform the ESG procedure to facilitate weight loss in patients with obesity (BMI 30 to 50 kg/m2). The FDA identifies this generic type of device as an Endoscopic suturing device for altering gastric anatomy for weight loss.

Locations (2)

Houston Methodist Hospital

Houston, Texas, United States

Houston Methodist Hospital - Sugarland

Sugar Land, Texas, United States