RECRUITING

Endoscopic Sleeve Gastroplasty (ESG) for the Treatment of Obesity

Conditions

Endoscopic Sleeve Gastroplasty Obesity Weight loss Endoscopic Sleeve Gastroplasty (ESG)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

Endoscopic Sleeve Gastroplasty (ESG) for the Treatment of Obesity

Quick Facts

Study Start:2024-02-28

Study Completion:2033-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06339320

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Thomas R McCarty, MD, MPH

CONTACT

713-363-7436

tommccarty3@houstonmethodist.org

Principal Investigator

Thomas R McCarty, MD, MPH

PRINCIPAL_INVESTIGATOR

The Methodist Hospital Research Institute

Study Locations (Sites)

Houston Methodist Hospital

Houston, Texas, 77030

United States

Houston Methodist Hospital - Sugarland

Sugar Land, Texas, 77479

United States

Collaborators and Investigators

Sponsor: The Methodist Hospital Research Institute

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

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

Study Start Date2024-02-28

Study Completion Date2033-10

Study Record Updates

Study Start Date2024-02-28

Study Completion Date2033-10

Terms related to this study

Keywords Provided by Researchers

Obesity
Weight loss
Endoscopic Sleeve Gastroplasty (ESG)

Additional Relevant MeSH Terms

Endoscopic Sleeve Gastroplasty
Obesity