Endoscopic Sleeve Gastroplasty (ESG) for the Treatment of Obesity

Not Applicable

Recruiting

• Conditions: Endoscopic Sleeve Gastroplasty; Obesity
• Interventions: Procedure: Endoscopic Sleeve Gastroplasty (ESG); Device: Apollo OverStitch endoscopic suturing device

• Registration Number: NCT06339320
• Lead Sponsor: The Methodist Hospital Research Institute

Brief 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).

Detailed Description

Obesity has become an epidemic on a national and international scale with immense burden of disease. Approximately one out of every three United States (U.S.) adults are characterized as having obesity with the global prevalence having nearly tripled over the last four decades to include over 650 million people. Although diet and exercise are essential, these interventions alone typically result in only 1-3% total weight loss. Pharmacotherapy is effective but has side effects and carries the risk of weight recurrence once discontinued. While bariatric surgery is the most robust treatment option, only 1% of eligible patients undergo surgery, leaving a tremendous need for effective and safe therapies.

Helping to bridge this gap in available treatments, the endoscopic sleeve gastroplasty (ESG) procedure provides a way to improve access to validated, efficacious, and safe anti-obesity treatments. ESG is an endoscopic weight loss procedure. The procedure uses an endoscopic suturing device, which has received FDA authorization as a minimally invasive procedure to facilitate weight loss for adults with obesity (BMI 30-50 kg/m2) 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. 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 procedure.

This study aims to perform ESG for patients with obesity, defined as a BMI 30-50 kg/m2. Additionally, data collection of relevant weight-related and metabolic outcomes, including comorbidity resolution will be collected retrospectively from the study to assess efficacy and safety of the ESG procedure. Data collection for the MBSAQIP registry will be recorded on a monthly basis.

Study Timeline

• Study Start: 2024-02-28
• Status Verified: 2024-03
• Study First Submitted: 2024-03-11
• Study First Submitted QC: 2024-03-24
• Last Update Submitted: 2024-03-24
• Study First Posted: 2024-04-01
• Last Update Posted: 2024-04-01
• Primary Completion: 2033-10
• Study Completion: 2033-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ESG Procedure	Endoscopic Sleeve Gastroplasty (ESG)	Endoscopic Sleeve Gastroplasty for patients with obesity using the Apollo OverStitch endoscopic suturing device.
ESG Procedure	Apollo OverStitch endoscopic suturing device	Endoscopic Sleeve Gastroplasty for patients with obesity using the Apollo OverStitch endoscopic suturing device.

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	30 days post-procedure	Treatment-related adverse events as assessed by CTCAE v4.0 will be reviewed on a monthly basis by the bariatric medical director, bariatric clinical review, and program manager. Per the U.S. FDA, identified risks to health including device- and/or procedure-related adverse events include: death, gastrointestinal bleeding, obstruction, perforation, injury to organs adjacent to the stomach, perigastric leak, and nausea, infection, pain, pneumoperitoneum, pneumothorax, and pulmonary embolism, weight gain, and adverse tissue reaction. All patients are recorded and entered into this MBSAQIP registry with outcomes tracked in real-time via the electronic medical record, and all ESG complications discussed at the Metabolic and Bariatric Surgery Committee Meetings which are held quarterly. This includes monitoring emergency department visits, readmissions, and patient transfers to any inpatient facility during the 30-day postoperative period.
Number of participants with technically successful completion of the ESG procedure	Procedural completion over 10 year period	Per the ASMBS, IRB approval must be for performing the ESG procedure, and not solely for data collection of outcomes from these procedures, with data collected by the MBSAQIP registry. Therefore, the primary outcome is performing the ESG procedure (defined as ability to successful complete the procedure). Procedural success will be defined by ability to successful reduce the size of the stomach using the Apollo OverStitch or APOLLO ESG and ESG SX systems. Technical success further identified by ability to insert the endoscopic suturing device, perform endoscopic reduction of the stomach, and success removal of the device.

Secondary Outcome Measures

Name	Time	Method
Change in body mass index (BMI) measured by kg/m2	BMI (kg/m2) measured day of procedure, 4 weeks, 3 months, 6 months, and 12 month intervals	Data collection of relevant weight-related outcomes, including body mass index (BMI, measured in kg/m2) will be performed on day of procedure and at relevant follow-up periods (day of procedure, 4 weeks, 3 months, 6 months, and 12 month intervals). From this, change in BMI with be measured to determine change at relevant follow-up intervals.
Change in hemoglobin A1C (%)	A1C measured pre-procedure, 3 months, 6 months, and 12 month intervals	Data collection of relevant comorbidity-related outcomes, including A1C (measured in percentage) will be performed pre-procedure and at relevant follow-up periods (pre-procedure, 3 months, 6 months, and 12 month intervals). This will be measured for all patients, regardless of presence or absence of diabetes mellitus (DM). From this, change in A1C will be calculated to determine and change in blood glucose (A1C).

Trial Locations

Locations (2)

Houston Methodist Hospital; 🇺🇸 Houston, Texas, United States

Houston Methodist Hospital - Sugarland; 🇺🇸 Sugar Land, Texas, United States