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Procedure

Endoscopic Sleeve Gastroplasty Techniques for Obesity

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
No Placebo-Only Group

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse Events
Percent TWL (%TWL)
Secondary study objectives
Gastric Emptying
Improvement in fasting lipids profile
Number of participants with a change in ghrelin hormone values
+7 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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).

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
2 Trials studying Obesity
1,200 Patients Enrolled for Obesity
Brigham and Women's HospitalLead Sponsor
1,670 Previous Clinical Trials
11,878,256 Total Patients Enrolled
47 Trials studying Obesity
278,114 Patients Enrolled for Obesity
Christopher C Thompson, MD, MScPrincipal InvestigatorBrigham and Women's Hospital
~7 spots leftby Jul 2026
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