Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss

Mass General Brigham

Status: Begins enrollment in 6 months

Conditions: Weight, Body; Obesity; Metabolic Disease; Obesity, Morbid

Treatments: Device: Endoscopic Sleeve Gastroplasty - Belt; Device: Endoscopic Sleeve Gastroplasty - Belt and Suspenders

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06299644

2023P003282

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Belt and Suspenders Configuration

Active Comparator group

Description:

Endoscopic sleeve gastroplasty with the Endomina system creating proximal and distal gastric plications (belt and suspenders configuration).

Treatment:

Device: Endoscopic Sleeve Gastroplasty - Belt and Suspenders

Belt Configuration

Active Comparator group

Description:

Endoscopic sleeve gastroplasty with the Endomina system creating distal gastric plications (belt configuration).

Treatment:

Device: Endoscopic Sleeve Gastroplasty - Belt