NCT06339320Recruiting
Endoscopic Sleeve Gastroplasty (ESG) for the Treatment of Obesity
Source: ClinicalTrials.gov · Last updated 1 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 11 Mar 2024
- Start date
- 28 Feb 2024
- Primary completion date
- Oct 2033
- Lead sponsor
- The Methodist Hospital Research Institute
- Diseases
- Obesity
- NCT number
- NCT06339320
What you commit to
- Study type: Interventional
- Planned participants: 150
- From 28 Feb 2024 to the primary completion date, Oct 2033
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active tobacco use (defined as tobacco within 4 weeks prior to the procedure)
- Severe coagulopathy and antiplatelet/anticoagulant therapy that cannot be corrected
Other illness
- 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)
- 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)
Other
- Patients who are actively pregnant
- Active gastric mucosal lesions
- Hiatal hernia \>5 cm
- Patients with endoscopic interventions that are contraindicated
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Houston Methodist Hospital Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Houston Methodist Hospital - Sugarland Coordinator of this site? Confirm its status | Sugar Land | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.