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โ† Trials
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Endoscopic Sleeve Gastroplasty (ESG) for the Treatment of Obesity

RecruitingNAAges 18 Years - anyAllThe Methodist Hospital Research Institute
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Endoscopic Sleeve Gastroplasty (ESG)
  • Apollo OverStitch endoscopic suturing device
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Where

2 sites
Houston Methodist Hospital
Houston, United States
Houston Methodist Hospital - Sugarland
Sugar Land, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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