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Procedure

Belt and Suspenders Configuration for Metabolic Diseases

N/A

Waitlist Available

Led By Christopher C Thompson, MD, MSc

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months, 12 months

Awards & highlights

Study Summary

"This trial will compare two different methods of placing sutures in the stomach to see which one leads to more weight loss. The study will use the Endomina system to measure the amount of weight lost

Who is the study for?

This trial is for individuals struggling with obesity who are looking to lose weight. Participants should be adults willing to undergo an endoscopic procedure, but those with certain gastrointestinal conditions or previous stomach surgeries may not qualify.Check my eligibility

What is being tested?

The study is testing two techniques of Endoscopic Sleeve Gastroplasty (ESG) using the Endomina system: one called 'Belt' and another 'Belt and Suspenders'. The goal is to see which method leads to more weight loss.See study design

What are the potential side effects?

Possible side effects from ESG procedures include sore throat, abdominal pain, nausea, vomiting, bloating, bleeding, and in rare cases perforation of the stomach.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months, 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months, 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months, 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse Events

Percent TWL (%TWL)

Secondary outcome measures

Gastric Emptying

Improvement in fasting lipids profile

Number of participants with a change in ghrelin hormone values

+7 more

Trial Design

2Treatment groups

Active Control

Group I: Belt and Suspenders ConfigurationActive Control1 Intervention

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

Group II: Belt ConfigurationActive Control1 Intervention

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Endo Tools Therapeutics S.A.Industry Sponsor

3 Previous Clinical Trials

1,210 Total Patients Enrolled

Brigham and Women's HospitalLead Sponsor

1,614 Previous Clinical Trials

11,470,825 Total Patients Enrolled

Christopher C Thompson, MD, MScPrincipal InvestigatorBrigham and Women's Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the clinical trial open to participants who are 60 years old and above?

"Individuals aged over 18 years and under 65 years are eligible for participation in this clinical trial."

Answered by AI

Is the enrollment for participants currently open in this clinical trial?

"As per clinicaltrials.gov, this particular investigation is currently inactive in terms of patient recruitment. Initially shared on May 1st, 2025, the most recent update was made on March 6th, 2024. Despite this study being temporarily closed to enrollment, there are a total of 1329 ongoing studies actively seeking participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss

Christopher C. Thompson, MD, MSc 2025. "Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06299644.

All > Morbid Obesity