Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss

November 25, 2025 updated by: Christopher C. Thompson, MD, MSc, Brigham and Women's Hospital

Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss Using the Endomina Plicating Device: A Randomized Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Belt and Suspenders Configuration
Endoscopic sleeve gastroplasty with the Endomina system creating proximal and distal gastric plications (belt and suspenders configuration).
Device: Endoscopic Sleeve Gastroplasty - Belt and Suspenders
Endoscopic sleeve gastroplasty using belt and suspender plications.
Other Names:
  • Belt and Suspenders ESG
Active Comparator: Belt Configuration
Endoscopic sleeve gastroplasty with the Endomina system creating distal gastric plications (belt configuration).
Device: Endoscopic Sleeve Gastroplasty - Belt
Endoscopic sleeve gastroplasty using belt only plications.
Other Names:
  • Belt ESG

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric Emptying
Time Frame: 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
Baseline, 6 month, 12 months
Number of participants with improvement in fasting glucose
Time Frame: Baseline, 6 months, 12 months
Change in fasting glucose laboratory values from baseline at 6 and 12 months post-procedure
Baseline, 6 months, 12 months
Number of participants with improvement in Hemoglobin A1c (HgA1c %)
Time Frame: Baseline, 6 months, 12 months
Change in HgA1c laboratory values from baseline at 6 and 12 months post-procedure
Baseline, 6 months, 12 months
Improvement in fasting lipids profile
Time Frame: Baseline, 6 months, 12 months
Change in fasting lipids laboratory values from baseline at 6 and 12 months post-procedure
Baseline, 6 months, 12 months
Number of participants with a change in ghrelin hormone values
Time Frame: Baseline, 6 months, 12 months
Change in ghrelin laboratory values from baseline at 6 and 12 months post-procedure
Baseline, 6 months, 12 months
Obesity-related comorbidities - hypertension
Time Frame: 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
Baseline, 6 months, 12 months
Obesity-related comorbidities - change in hypertension concomitant medications
Time Frame: 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
Baseline, 6 months, 12 months
Obesity-related comorbidities - change in pre-diabetes/diabetes concomitant medications
Time Frame: 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
Baseline, 6 months, 12 months
Obesity-related comorbidities - pre-diabetes/diabetes
Time Frame: 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
Baseline, 6 months, 12 months
Obesity-related comorbidities - gastroesophageal reflux (GERD)
Time Frame: 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
Baseline, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

Endo Tools Therapeutics S.A.

Investigators

  • Principal Investigator: Christopher C Thompson, MD, MSc, Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

February 1, 2024

First Submitted That Met QC Criteria

March 6, 2024

First Posted (Actual)

March 8, 2024

Study Record Updates

Last Update Posted (Actual)

December 2, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023P003282

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data will be shared with other researchers upon written request to the PI. If PI approves of the research plan, data will be released after an Institutional Data Sharing Agreement is in place.

IPD Sharing Time Frame

12 months after publication of results. Available for 10 years.

IPD Sharing Access Criteria

Formal written request to PI with research proposal/plan.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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