Endoscopic Sleeve Gastroplasty (ESG) for the Treatment of Obesity

The Methodist Hospital Research Institute (TMHRI)

Status

Enrolling

Conditions

Endoscopic Sleeve Gastroplasty

Obesity

Treatments

Procedure: Endoscopic Sleeve Gastroplasty (ESG)

Device: Apollo OverStitch endoscopic suturing device

Study type

Interventional

Funder types

Other

Identifiers

NCT06339320

PRO00037835

Details and patient eligibility

About

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).

Full 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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

Patients who are actively pregnant
Active tobacco use (defined as tobacco within 4 weeks prior to the procedure)
Active gastric mucosal lesions
Active bleeding or potential bleeding gastric lesions (i.e., ulcers, erosive gastritis, varices, or vascular malformations)
Neoplastic lesions (i.e., esophageal, gastric, or small bowel cancer)
Hiatal hernia >5 cm
Severe coagulopathy and antiplatelet/anticoagulant therapy that cannot be corrected
Psychiatric disorders not assessed or cleared by a psychologist or psychiatrist actively participating in that patient's care (i.e., affective disorders not under medical supervision or refractory to medical therapy and all eating disorders such as anorexia nervosa, binge eating disorder, specified feeding and eating disorders, avoidant restrictive food intake, and rumination)
Patients with endoscopic interventions that are contraindicated