Endoscopic Sleeve Gastroplasty for treating obesity
Endoscopic Sleeve Gastroplasty (ESG) for the Treatment of Obesity
This study is testing if a new procedure called endoscopic sleeve gastroplasty can help people with obesity lose weight when diet and exercise haven't worked for them.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Methodist Hospital Research Institute Academic / other |
| Locations | 2 sites (Houston, Texas and 1 other locations) |
| Trial ID | NCT06339320 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of endoscopic sleeve gastroplasty (ESG) as a treatment for obesity in patients with a body mass index (BMI) between 30 and 50 kg/m2. ESG is a minimally invasive procedure that reduces the stomach's volume by approximately 70-80% using an endoscopic suturing device. The goal is to provide a safe and effective alternative for individuals who have struggled to lose weight through traditional methods such as diet and exercise. The study is conducted at accredited centers that have received Institutional Review Board approval to perform this procedure.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with a BMI between 30 and 50 kg/m2 who have not achieved weight loss through conservative measures.
Not a fit: Patients who are pregnant, actively using tobacco, or have certain gastric conditions or severe coagulopathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this procedure could offer a new, effective treatment option for patients struggling with obesity.
How similar studies have performed: Other studies have shown promising results with similar endoscopic procedures for weight loss, indicating potential for success with ESG.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Houston, Texas and 1 other locations
- Houston Methodist Hospital — Houston, Texas, United States (Recruiting)
- Houston Methodist Hospital - Sugarland — Sugar Land, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Thomas R McCarty, MD, MPH — The Methodist Hospital Research Institute
- Study coordinator: Thomas R McCarty, MD, MPH
- Email: tommccarty3@houstonmethodist.org
- Phone: 713-363-7436
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.