NCT06339320

Endoscopic Sleeve Gastroplasty (ESG) for the Treatment of Obesity

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: The Methodist Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Obesity has become an epidemic on a national and international scale with immense burden of disease. Approximately one out of every three United States (U.S.) adults are characterized as having obesity with the global prevalence having nearly tripled over the last four decades to include over 650 million people. Although diet and exercise are essential, these interventions alone typically result in only 1-3% total weight loss. Pharmacotherapy is effective but has side effects and carries the risk of weight recurrence once discontinued. While bariatric surgery is the most robust treatment option, only 1% of eligible patients undergo surgery, leaving a tremendous need for effective and safe therapies. Helping to bridge this gap in available treatments, the endoscopic sleeve gastroplasty (ESG) procedure provides a way to improve access to validated, efficacious, and safe anti-obesity treatments. ESG is an endoscopic weight loss procedure. The procedure uses an endoscopic suturing device, which has received FDA authorization as a minimally invasive procedure to facilitate weight loss for adults with obesity (BMI 30-50 kg/m2) 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. 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 procedure. This study aims to perform ESG for patients with obesity, defined as a BMI 30-50 kg/m2. Additionally, data collection of relevant weight-related and metabolic outcomes, including comorbidity resolution will be collected retrospectively from the study to assess efficacy and safety of the ESG procedure. Data collection for the MBSAQIP registry will be recorded on a monthly basis.

Conditions

• Endoscopic Sleeve Gastroplasty
• Obesity

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-02-28
• Primary completion: 2033-10-01
• Completion: 2033-10-01
• First posted: 2024-04-01
• Last updated: 2024-04-01

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study