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Observational Study of Endoscopic Sleeve Gastroplasty (ESG) for Weight Loss

This study is looking at the long-term effects of Endoscopic Sleeve Gastroplasty (ESG), a procedure that helps with weight loss, five or more years after it was performed. Researchers want to understand how well people maintain their weight loss over time after having ESG. You may be able to join if you are at least 18 years old, had an ESG procedure using the Overstitch Endoscopic Suturing System, and had a body mass index (BMI) between 30 and 50 at the time of your ESG. The study will consider ESG successful if a certain number of participants maintain a significant amount of weight loss five years after their procedure. The current status of this study is unclear.

Study design
This is an observational study that plans to enroll 100 participants. It involves looking back at past medical information and one future visit.
What's involved
You would participate in one prospective visit and your past medical records would be reviewed.
Compensation
Not stated in the trial record.
Follow-up
Participants are followed up to five years after their ESG procedure.

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NCT06894498

Five PLus Year EffIcacy of Endoscopic Sleeve Gastroplasty (ESG) for Sustained WeigHT Loss

Terminated
Not specifiedAges 18+Observational
Boston Scientific Corporation
~2 participants
Updated 2026-08-31 on ClinicalTrials.gov
What's tested:No Intervention: Observational Cohort

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of subjects that maintain clinically significant weightloss at five-year visit
Measured over TBWL assessed at five-years post ESG

Conditions

Obesity and Obesity-related Medical Conditions
Weight Loss

Explore related trials

Obesity

Where it's being run

2 sites across 2 states
Illinois1
Texas1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Subject is ≥ 18 years of age at the time of the ESG procedure
Subject with a BMI between 30 kg/m2 and 50 kg/m2, inclusive, at the time of the primary ESG procedure using Overstitch Endoscopic Suturing System
Subject completed follow-up 1-year from the ESG procedure for weight loss management
Subject completed or is eligible for follow-up 5-years from the ESG procedure for weight loss management (visit can be collected either retrospectively or prospectively)
Subject has returned for a minimum of one annual follow-up at the treating site for weight loss management annually between two and four years from the procedure.
Subject is willing to complete one prospective visit (5 year or 5+ year, as appropriate)
Subject is able to read, understand, and sign a written Informed Consent Form to participate in the study

Exclusion

None

What this trial measures

  • Proportion of subjects that maintain clinically significant weightloss at five-year visitTBWL assessed at five-years post ESG

    Mean % Total Body Weight Loss (TBWL) at 5-year visit.