Obesity and Obesity-related Medical Conditions, Weight Loss
Conditions
Brief summary
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.
Detailed description
Includes retrospective data collection and one prospective visit
Interventions
OTHERNo Intervention: Observational Cohort
No Intervention, Observational Cohort
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects that maintain clinically significant weightloss at five-year visit | TBWL assessed at five-years post ESG | Mean % Total Body Weight Loss (TBWL) at 5-year visit. |
Countries
United States
Outcome results
None listed