Endoscopic Sleeve Gastroplasty for treating obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of endoscopic sleeve gastroplasty (ESG) as a treatment for obesity in patients with a body mass index (BMI) between 30 and 50 kg/m2. ESG is a minimally invasive procedure that reduces the stomach's volume by approximately 70-80% using an endoscopic suturing device. The goal is to provide a safe and effective alternative for individuals who have struggled to lose weight through traditional methods such as diet and exercise. The study is conducted at accredited centers that have received Institutional Review Board approval to perform this procedure.

Why it matters

Who can join: the full rules

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

Where it's running

• Houston Methodist Hospital
  Houston, Texas, United States Recruiting
• Houston Methodist Hospital - Sugarland
  Sugar Land, Texas, United States Recruiting

Study contacts

• Principal investigator: Thomas R McCarty, MD, MPH — The Methodist Hospital Research Institute
• Study coordinator: Thomas R McCarty, MD, MPH
• Email: tommccarty3@houstonmethodist.org
• Phone: 713-363-7436

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.