Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06299644

Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Endoscopic Sleeve Gastroplasty - Belt and Suspenders

Device

Endoscopic sleeve gastroplasty using belt and suspender plications.

Other names: Belt and Suspenders ESG

Endoscopic Sleeve Gastroplasty - Belt

Device

Endoscopic sleeve gastroplasty using belt only plications.

Other names: Belt ESG

Primary outcomes

  1. Percent TWL (%TWL)

    Time frame: Baseline, 6 months, 12 months

    Change in the percent total weight loss from baseline at 6 and 12 months.

  2. Adverse Events

    Time frame: 6 months, 12 months

    Presence of adverse events that develop post-procedure

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Michele B Ryan, MS

CONTACT

[email protected]

617-525-8266

Samantha Geltz

CONTACT

[email protected]

617-525-8266

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Endo Tools Therapeutics S.A.

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 8, 2024
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.