NCT06339320 Endoscopic Sleeve Gastroplasty (ESG) for the Treatment of Obesity
| NCT ID | NCT06339320 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Methodist Hospital Research Institute |
| Condition | Endoscopic Sleeve Gastroplasty |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-02-28 |
| Primary Completion | 2033-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2024-02-28 with a primary completion date of 2033-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility 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
Contact & Investigator
Thomas R McCarty, MD, MPH
PRINCIPAL INVESTIGATOR
The Methodist Hospital Research Institute
Frequently Asked Questions
Who can join the NCT06339320 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Endoscopic Sleeve Gastroplasty. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06339320 currently recruiting?
Yes, NCT06339320 is actively recruiting participants. Contact the research team at tommccarty3@houstonmethodist.org for enrollment information.
Where is the NCT06339320 trial being conducted?
This trial is being conducted at Houston, United States, Sugar Land, United States.
Who is sponsoring the NCT06339320 clinical trial?
NCT06339320 is sponsored by The Methodist Hospital Research Institute. The principal investigator is Thomas R McCarty, MD, MPH at The Methodist Hospital Research Institute. The trial plans to enroll 150 participants.