Actively Recruiting
Endoscopic Sleeve Gastroplasty (ESG) for the Treatment of Obesity
Led by The Methodist Hospital Research Institute · Updated on 2024-04-01
150
Participants Needed
2
Research Sites
500 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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).
CONDITIONS
Official Title
Endoscopic Sleeve Gastroplasty (ESG) for the Treatment of Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with BMI 30 to 50 kg/m2
- Patients unable to lose weight or maintain weight loss through diet and exercise
- Lifestyle interventions may include diet and aerobic or anaerobic exercise, including resistance training
You will not qualify if you...
- Patients who are actively pregnant
- Active tobacco use within 4 weeks prior to the procedure
- Active gastric mucosal lesions
- Active bleeding or potential bleeding gastric lesions such as ulcers, erosive gastritis, varices, or vascular malformations
- Neoplastic lesions including esophageal, gastric, or small bowel cancer
- Hiatal hernia larger than 5 cm
- Severe coagulopathy or antiplatelet/anticoagulant therapy that cannot be corrected
- Psychiatric disorders not cleared by a psychologist or psychiatrist involved in the patient's care, including untreated affective disorders and all eating disorders
- Patients with contraindications to endoscopic interventions
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
2
Houston Methodist Hospital - Sugarland
Sugar Land, Texas, United States, 77479
Actively Recruiting
Research Team
T
Thomas R McCarty, MD, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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