RecruitingNot ApplicableNCT06339320

Endoscopic Sleeve Gastroplasty (ESG) for the Treatment of Obesity

Sponsor

The Methodist Hospital Research Institute

Enrollment

150 participants

Start Date

Feb 28, 2024

Study Type

INTERVENTIONAL

Conditions

Obesity Endoscopic Sleeve Gastroplasty

Summary

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).

Eligibility

Min Age: 18 Years

Inclusion Criteria2

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 Criteria9

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

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Interventions

PROCEDUREEndoscopic Sleeve Gastroplasty (ESG)

The ESG procedure uses the Apollo OverStitch endoscopic suturing device, which has received FDA authorization as a minimally invasive procedure to facilitate weight loss for adults with who have been unable to lose weight or maintain weight loss through more conservative measures such as diet and exercise. This procedure involves endoscopic suturing to reduce the volume of the stomach endoscopically by approximately 70% to 80% its original size. Using the Apollo OverStitch or APOLLO ESG and ESG SX Systems, the ESG procedure is performed be folding the stomach in on itself (endoscopically) and placing full-thickness sutures through the wall of the stomach to maintain this narrow, smaller size. Following the procedure, the new stomach appears similar to the surgical sleeve stomach, although the procedure is considered less invasive with fewer complications compared to a surgical sleeve gastrectomy.

DEVICEApollo OverStitch endoscopic suturing device

Apollo ESG is the first and only device to be authorized by the FDA to perform the ESG procedure to facilitate weight loss in patients with obesity (BMI 30 to 50 kg/m2). The FDA identifies this generic type of device as an Endoscopic suturing device for altering gastric anatomy for weight loss.