Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss

Not Applicable

Not yet recruiting

• Conditions: Metabolic Disease; Weight, Body; Obesity; Obesity, Morbid
• Interventions: Device: Endoscopic Sleeve Gastroplasty - Belt and Suspenders; Device: Endoscopic Sleeve Gastroplasty - Belt

• Registration Number: NCT06299644
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

The Investigators propose suture plication placement at the distal gastric body drives a significant portion of weight loss in endoscopic sleeve and sutures only need to be placed in the distal gastric body. Therefore, in this pilot study, the investigators aim to compare "belt" with "belt and suspenders" plication pattern using the Endomina system to determine percent total weight loss.

Detailed Description

Obesity is a major global health concern. In the US, from 1999 through 2020, the prevalence of obesity has increased from 30.5% to 41.9%. Obesity, defined as the body mass index of more than 30 kg/m2, increases the risk of metabolic diseases and has become the leading cause of death including cardiovascular disease, stroke and cancers.

At present, obesity treatment ranges from lifestyle modification, pharmacotherapy, endoscopic to surgical intervention. Though bariatric surgery has proven to be the most effective treatment in terms of weight loss, it still carries the complication rates of 0.6% - 4.9%.

Endoscopic Bariatric and Metabolic Therapy (EBMT) has emerged as an alternative minimally invasive approach for the patients with morbid obesity with the body mass index (BMI) of 30 - 40 kg/m2. Endoscopic sleeve gastroplasty (ESG) involves placing sutures inside the stomach using an endoluminal full-thickness suturing device. This allows for gastric volume reduction and impaired gastric motility, which results in weight loss. Recent meta-analysis demonstrated ESG, using OverStitch suturing device, percent total weight loss (%TWL) of 16.09 - 16.43% at 12 months after procedure and a serious adverse event rate of 1 - 2.26%. With favorable outcomes and lower complication rates compared to bariatric surgery, ESG has been growing in popularity and increasingly performed worldwide. Other EBT cleared by the U.S. Food and Drug Administration for full thickness tissue approximation include the Incisionless Operating Platform endoscopic plication (USGI Medical, San Clemente, Calif, USA), and Endomina® (Endo Tools Therapeutic, Gosselies, Belgium) which creates gastric plications.

Currently, there is no standardization regarding suturing patterns. One suture pattern for gastric plication that has been used is the "belt and suspenders" pattern whereby plications sutures are placed in the distal gastric body along the width (belt) and mid/proximal gastric body (suspenders). This allows for gastric shortening and reduction in gastric volume. It is suspected this would also alter gastric motility. The distal gastric plications placed near the antrum would result in a disruption of gastric motility; decreased gastric motility would result in decrease gastric emptying and longer satiety.

Study Timeline

• Study First Submitted: 2024-02-01
• Study First Submitted QC: 2024-03-06
• Study First Posted: 2024-03-08
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-26
• Last Update Posted: 2024-07-29
• Study Start: 2025-05-01
• Primary Completion: 2026-07-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Patients with 18-65 years of age
2. BMI ≥ 30 kg/m2
3. Capable of giving informed consent and available to return for follow-up visit

Exclusion Criteria

1. Untreated H. pylori infection
2. Active gastric or duodenal ulceration
3. Malignant or premalignant gastric diseases (such as intestinal metaplasia, high grade dysplasia, gastric adenocarcinoma, or gastrointestinal stromal tumor (GIST))
4. Severe reflux esophagitis (Los Angeles Classification (LA) Grade C or D)
5. Esophageal or gastric varices and/or portal hypertensive gastropathy
6. Gastroparesis
7. History of gastric surgery/endoscopic procedure
8. Active psychological issues preventing participation in a lifestyle modification program
9. Known history of endocrine disorders affecting weight (uncontrolled hypothyroidism)
10. Severe coagulopathy
11. Active smoking
12. Substance abuse
13. Serious health condition that increased risk of anesthesia and/or endoscopic procedure
14. Pregnancy or lactation
15. Patients who require Non-Steroidal Anti-inflammatory Drugs (NSAID) use

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Belt and Suspenders Configuration	Endoscopic Sleeve Gastroplasty - Belt and Suspenders	Endoscopic sleeve gastroplasty with the Endomina system creating proximal and distal gastric plications (belt and suspenders configuration).
Belt Configuration	Endoscopic Sleeve Gastroplasty - Belt	Endoscopic sleeve gastroplasty with the Endomina system creating distal gastric plications (belt configuration).

Primary Outcome Measures

Name	Time	Method
Percent TWL (%TWL)	Baseline, 6 months, 12 months	Change in the percent total weight loss from baseline at 6 and 12 months.
Adverse Events	6 months, 12 months	Presence of adverse events that develop post-procedure

Secondary Outcome Measures

Name	Time	Method
Gastric Emptying	Baseline, 6 month, 12 months	Comparison of gastric emptying rate using Gastric Emptying Breath Test (GEBT) from baseline to 6 months and 12 months post-procedure
Obesity-related comorbidities - pre-diabetes/diabetes	Baseline, 6 months, 12 months	Change in diabetes/pre-diabetes diagnosis/status via change in HgA1c measurements (%) at 6 months and 12 months from baseline
Obesity-related comorbidities - gastroesophageal reflux (GERD)	Baseline, 6 months, 12 months	Change in GERD diagnosis/status via change in proton pump inhibitor (PPI) or related medications for treatment of GERD at 6 months and 12 months
Number of participants with improvement in fasting glucose	Baseline, 6 months, 12 months	Change in fasting glucose laboratory values from baseline at 6 and 12 months post-procedure
Number of participants with improvement in Hemoglobin A1c (HgA1c %)	Baseline, 6 months, 12 months	Change in HgA1c laboratory values from baseline at 6 and 12 months post-procedure
Obesity-related comorbidities - change in hypertension concomitant medications	Baseline, 6 months, 12 months	Change in hypertension diagnosis/status via change blood pressure related medication dosage (mg) at 6 months and 12 months from baseline
Improvement in fasting lipids profile	Baseline, 6 months, 12 months	Change in fasting lipids laboratory values from baseline at 6 and 12 months post-procedure
Number of participants with a change in ghrelin hormone values	Baseline, 6 months, 12 months	Change in ghrelin laboratory values from baseline at 6 and 12 months post-procedure
Obesity-related comorbidities - hypertension	Baseline, 6 months, 12 months	Change in hypertension diagnosis/status via change in blood pressure measurements (systolic and diastolic mm Hg) at 6 months and 12 months from baseline
Obesity-related comorbidities - change in pre-diabetes/diabetes concomitant medications	Baseline, 6 months, 12 months	Change in diabetes/pre-diabetes diagnosis/status via change in diabetes medications dosages (mg) at 6 months and 12 months from baseline

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States