Endoscopic Sleeve Gastroplasty (ESG) for the Treatment of Obesity
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:
🦠 Endoscopic Sleeve Gastroplasty 🦠 Obesity
🗓️ Study Start (Actual) 28 February 2024
🗓️ Primary Completion (Estimated) October 2033
✅ Study Completion (Estimated) October 2033
👥 Enrollment (Estimated) 150
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Houston, Texas, United States
📍 Sugar Land, Texas, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 11 March 2024
  • First Submitted that Met QC Criteria 24 March 2024
  • First Posted 1 April 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 24 March 2024
  • Last Update Posted 1 April 2024
  • Last Verified March 2024