Endoscopic Sleeve Gastroplasty (ESG) for the Treatment of Obesity

NARecruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

February 28, 2024

Primary Completion Date

October 31, 2033

Study Completion Date

October 31, 2033

Conditions
Endoscopic Sleeve GastroplastyObesity
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.

Trial Locations (2)

77030

RECRUITING

Houston Methodist Hospital, Houston

77479

RECRUITING

Houston Methodist Hospital - Sugarland, Sugar Land

All Listed Sponsors
lead

The Methodist Hospital Research Institute

OTHER