Endoscopic Sleeve Gastroplasty (ESG) for the Treatment of Obesity

Description

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

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Study Overview

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Study Details

Study overview

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).

Endoscopic Sleeve Gastroplasty (ESG) for the Treatment of Obesity

Endoscopic Sleeve Gastroplasty (ESG) for the Treatment of Obesity

Condition
Endoscopic Sleeve Gastroplasty
Intervention / Treatment

-

Contacts and Locations

Houston

Houston Methodist Hospital, Houston, Texas, United States, 77030

Sugar Land

Houston Methodist Hospital - Sugarland, Sugar Land, Texas, United States, 77479

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The Methodist Hospital Research Institute,

Thomas R McCarty, MD, MPH, PRINCIPAL_INVESTIGATOR, The Methodist Hospital Research Institute

Study Record Dates

2033-10