Five PLus Year EffIcacy of Endoscopic Sleeve Gastroplasty (ESG) for Sustained WeigHT Loss
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBoston Scientific Corporation
About this trial
The objective of this study is to assess the long term weight loss and weight loss journey of patients who received an Endoscopic Sleeve Gastroplasty (ESG) 5 or more years prior to enrollment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
None
Trial population
Study participants will be selected from weight loss or bariatric centers
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
No Intervention: Observational Cohort
Other interventionNo Intervention, Observational Cohort
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Proportion of subjects that maintain clinically significant weightloss at five-year visit
Mean % Total Body Weight Loss (TBWL) at 5-year visit.
Time frame
TBWL assessed at five-years post ESGSponsors and contacts
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Source ClinicalTrials.gov