An interventional study of Endoscopic Sleeve Gastroplasty - Belt and Suspenders and Endoscopic Sleeve Gastroplasty - Belt in Obesity, Obesity, Morbid and Metabolic Disease, sponsored by Brigham and Women's Hospital. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Treatment
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.
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.
941 studies on the registry are indexed under Obesity, Morbid; 163 are open to participants now.
This study's planned enrollment of 10 is below the median of 62 across 602 interventional studies indexed under Obesity, Morbid.
Browse Obesity, Morbid studies →Brigham and Women's Hospital is the lead sponsor of 1,267 studies on the registry; 228 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
Compared within Obesity, Morbid, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Obesity. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 with the Endomina system creating distal gastric plications (belt configuration).
Device: Endoscopic Sleeve Gastroplasty - Belt
Endoscopic sleeve gastroplasty using belt and suspender plications.
Also known as: Belt and Suspenders ESG
Endoscopic sleeve gastroplasty using belt only plications.
Also known as: Belt ESG
Percent TWL (%TWL)
Change in the percent total weight loss from baseline at 6 and 12 months.
Time frame: Baseline, 6 months, 12 months
Adverse Events
Presence of adverse events that develop post-procedure
Time frame: 6 months, 12 months
Gastric Emptying
Comparison of gastric emptying rate using Gastric Emptying Breath Test (GEBT) from baseline to 6 months and 12 months post-procedure
Time frame: Baseline, 6 month, 12 months
Number of participants with improvement in fasting glucose
Change in fasting glucose laboratory values from baseline at 6 and 12 months post-procedure
Time frame: Baseline, 6 months, 12 months
Number of participants with improvement in Hemoglobin A1c (HgA1c %)
Change in HgA1c laboratory values from baseline at 6 and 12 months post-procedure
Time frame: Baseline, 6 months, 12 months
Improvement in fasting lipids profile
Change in fasting lipids laboratory values from baseline at 6 and 12 months post-procedure
Time frame: Baseline, 6 months, 12 months
Number of participants with a change in ghrelin hormone values
Change in ghrelin laboratory values from baseline at 6 and 12 months post-procedure
Time frame: Baseline, 6 months, 12 months
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
Time frame: Baseline, 6 months, 12 months
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
Time frame: Baseline, 6 months, 12 months
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
Time frame: Baseline, 6 months, 12 months
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
Time frame: Baseline, 6 months, 12 months
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
Time frame: Baseline, 6 months, 12 months
Plan to share: 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.
Supporting information: Study protocol, Informed consent form, Clinical study report
Time frame: 12 months after publication of results. Available for 10 years.
Access criteria: Formal written request to PI with research proposal/plan.
Start is estimated for Sep 2026; primary completion for Oct 2027, 13 months later.
Of 274 non-industry interventional studies with no phase under Obesity, Morbid, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 48. This study's planned 13 months is below that.
Counting every sponsor, half of 286 studies reached it within 25 months; a quarter within 11 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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