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ObesityNCT06299644

Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss

A study testing Endoscopic Sleeve Gastroplasty - Belt and Suspenders and Endoscopic Sleeve Gastroplasty - Belt in people with Obesity and Obesity, Morbid, run by Brigham and Women's Hospital at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Obesity, Obesity, Morbid, Metabolic Disease
What is being tested?
Endoscopic Sleeve Gastroplasty - Belt and Suspenders and Endoscopic Sleeve Gastroplasty - Belt
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
Sep 2026to May 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Michele B Ryan, MS contact

617-525-8266

mryan@bwh.harvard.edu

Samantha Geltz contact

617-525-8266

sgeltz@bwh.harvard.edu

United States1 site

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Endoscopic Sleeve Gastroplasty - Belt and Suspenders, Endoscopic Sleeve Gastroplasty - Belt
Keywords
Endoscopic Bariatric and Metabolic Therapies (EBMT), Endoscopic Bariatric Therapies (EBT), Gastric emptying, Endoscopic Suturing, endoscopic sleeve gastroplasty (ESG), Weight Loss, Bariatric Endoscopy, Weight Management, Endoscopic plication, Gastric plication
Medical subject headings
Obesity, Obesity, Morbid, Metabolic Diseases, Body Weight, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endoscopic Sleeve Gastroplasty - Belt and SuspendersDevice

    Also called Belt and Suspenders ESG

    Endoscopic sleeve gastroplasty using belt and suspender plications.

  • Endoscopic Sleeve Gastroplasty - BeltDevice

    Also called Belt ESG

    Endoscopic sleeve gastroplasty using belt only plications.

Study groups in NCT06299644
Study groupRoleWhat they receive
Belt and Suspenders ConfigurationActive comparatorEndoscopic sleeve gastroplasty with the Endomina system creating proximal and distal gastric plications (belt and suspenders configuration).
Receives: Device: Endoscopic Sleeve Gastroplasty - Belt and Suspenders
Belt ConfigurationActive comparatorEndoscopic sleeve gastroplasty with the Endomina system creating distal gastric plications (belt configuration).
Receives: Device: Endoscopic Sleeve Gastroplasty - Belt

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent TWL (%TWL)

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

    Measured: Baseline, 6 months, 12 months

  2. Adverse Events

    Presence of adverse events that develop post-procedure

    Measured: 6 months, 12 months

Secondary outcomes (10)

  1. Gastric Emptying

    Comparison of gastric emptying rate using Gastric Emptying Breath Test (GEBT) from baseline to 6 months and 12 months post-procedure

    Measured: Baseline, 6 month, 12 months

  2. Number of participants with improvement in fasting glucose

    Change in fasting glucose laboratory values from baseline at 6 and 12 months post-procedure

    Measured: Baseline, 6 months, 12 months

  3. Number of participants with improvement in Hemoglobin A1c (HgA1c %)

    Change in HgA1c laboratory values from baseline at 6 and 12 months post-procedure

    Measured: Baseline, 6 months, 12 months

  4. Improvement in fasting lipids profile

    Change in fasting lipids laboratory values from baseline at 6 and 12 months post-procedure

    Measured: Baseline, 6 months, 12 months

  5. Number of participants with a change in ghrelin hormone values

    Change in ghrelin laboratory values from baseline at 6 and 12 months post-procedure

    Measured: Baseline, 6 months, 12 months

  6. Obesity-related comorbidities - hypertension

    Change in hypertension diagnosis/status via change in blood pressure measurements (systolic and diastolic mm Hg) at 6 months and 12 months from baseline

    Measured: Baseline, 6 months, 12 months

  7. Obesity-related comorbidities - change in hypertension concomitant medications

    Change in hypertension diagnosis/status via change blood pressure related medication dosage (mg) at 6 months and 12 months from baseline

    Measured: Baseline, 6 months, 12 months

  8. Obesity-related comorbidities - change in pre-diabetes/diabetes concomitant medications

    Change in diabetes/pre-diabetes diagnosis/status via change in diabetes medications dosages (mg) at 6 months and 12 months from baseline

    Measured: Baseline, 6 months, 12 months

  9. Obesity-related comorbidities - pre-diabetes/diabetes

    Change in diabetes/pre-diabetes diagnosis/status via change in HgA1c measurements (%) at 6 months and 12 months from baseline

    Measured: Baseline, 6 months, 12 months

  10. Obesity-related comorbidities - gastroesophageal reflux (GERD)

    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

    Measured: Baseline, 6 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2024
  2. Study startSep 2026 (estimated)
  3. Primary completionOct 2027 (estimated)
  4. Study completionMay 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06299644
Sponsor's protocol ID
2023P003282
Status last verified
Nov 2025
First submitted
1 Feb 2024
Last updated
2 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: 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.

Publications

  • Ibrahim AM, Ghaferi AA, Thumma JR, Dimick JB. Variation in Outcomes at Bariatric Surgery Centers of Excellence. JAMA Surg. 2017 Jul 1;152(7):629-636. doi: 10.1001/jamasurg.2017.0542.

    PubMed 28445566

  • Docimo S Jr, Aylward L, Albaugh VL, Afaneh C, El Djouzi S, Ali M, Altieri MS, Carter J; American Society for Metabolic and Bariatric Surgery Clinical Issues Committee. Endoscopic sleeve gastroplasty and its role in the treatment of obesity: a systematic review. Surg Obes Relat Dis. 2023 Nov;19(11):1205-1218. doi: 10.1016/j.soard.2023.08.020. Epub 2023 Sep 16. No abstract available.

    PubMed 37813705

  • Singh S, Hourneaux de Moura DT, Khan A, Bilal M, Ryan MB, Thompson CC. Safety and efficacy of endoscopic sleeve gastroplasty worldwide for treatment of obesity: a systematic review and meta-analysis. Surg Obes Relat Dis. 2020 Feb;16(2):340-351. doi: 10.1016/j.soard.2019.11.012. Epub 2019 Dec 10.

    PubMed 31932205

  • Li P, Ma B, Gong S, Zhang X, Li W. Efficacy and safety of endoscopic sleeve gastroplasty for obesity patients: a meta-analysis. Surg Endosc. 2020 Mar;34(3):1253-1260. doi: 10.1007/s00464-019-06889-6. Epub 2019 Jun 24.

    PubMed 31236722

  • Beran A, Matar R, Jaruvongvanich V, Rapaka BB, Alalwan A, Portela R, Ghanem O, Dayyeh BKA. Comparative Effectiveness and Safety Between Endoscopic Sleeve Gastroplasty and Laparoscopic Sleeve Gastrectomy: a Meta-analysis of 6775 Individuals with Obesity. Obes Surg. 2022 Nov;32(11):3504-3512. doi: 10.1007/s11695-022-06254-y. Epub 2022 Sep 2.

    PubMed 36053446

  • Jalal MA, Cheng Q, Edye MB. Systematic Review and Meta-Analysis of Endoscopic Sleeve Gastroplasty with Comparison to Laparoscopic Sleeve Gastrectomy. Obes Surg. 2020 Jul;30(7):2754-2762. doi: 10.1007/s11695-020-04591-4.

    PubMed 32304011

Questions about this trial

What is this clinical trial studying?

A study testing Endoscopic Sleeve Gastroplasty - Belt and Suspenders and Endoscopic Sleeve Gastroplasty - Belt in people with Obesity and Obesity, Morbid, run by Brigham and Women's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Michele B Ryan, MS (617-525-8266, mryan@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent TWL (%TWL) (time frame: Baseline, 6 months, 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06299644, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.

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