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Tests endoscopic sleeve gastroplasty for treating obesity in adults

Tests a procedure that narrows the stomach without surgery cuts, in adults with obesity.

Key facts

Who runs it
The Methodist Hospital Research Institute
Where
Houston and Sugar Land, United StatesSee the 2 sites
Trial code
Registry title
Endoscopic Sleeve Gastroplasty (ESG) for the Treatment of Obesity
Status
Recruiting
People taking part
150 people, planned
Started
28 Feb 2024
Expected to end
Oct 2033
Type of study
Interventional
Treatments tested
  • Endoscopic Sleeve Gastroplasty (ESG)
  • Apollo OverStitch endoscopic suturing device
Record updated
1 April 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with obesity (BMI 30 to 50 kg/m2) who could not lose weight, or keep it off, with diet and exercise. They would have endoscopic sleeve gastroplasty.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Obesity with a BMI of 30 to 50 kg/m2.
Earlier treatment
Must have been unable to lose weight, or keep weight off, with lifestyle measures such as diet and exercise.

Main reasons for not taking part

  • Currently pregnant
  • Active tobacco use (within 4 weeks before the procedure)
  • Active stomach lining damage, bleeding or possible bleeding stomach lesions
  • Cancer of the esophagus, stomach or small bowel
  • Hiatal hernia larger than 5 cm (2 in)

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Active tobacco use (defined as tobacco within 4 weeks prior to the procedure)
  • Severe coagulopathy and antiplatelet/anticoagulant therapy that cannot be corrected
  • 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)
  • 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 who are actively pregnant
  • Active gastric mucosal lesions
  • Hiatal hernia >5 cm
  • Patients with endoscopic interventions that are contraindicated

Where in United States

  • Houston Methodist HospitalHouston, United StatesContact: Thomas R McCarty, MD, MPHTaking people
  • Houston Methodist Hospital - SugarlandSugar Land, United StatesContact: Thomas R McCarty, MD, MPHTaking people

About the trial

What the trial wants to find out

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).

The group in the trial

  • ESG ProcedureOther group

    Endoscopic Sleeve Gastroplasty for patients with obesity using the Apollo OverStitch endoscopic suturing device.

    Treatment: Endoscopic Sleeve Gastroplasty (ESG) and Apollo OverStitch endoscopic suturing device

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Endoscopic Sleeve Gastroplasty (ESG) for the Treatment of Obesity
Plain-language title
Tests endoscopic sleeve gastroplasty for treating obesity in adultsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
1 April 2024