NCT06894498

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2025

Completed
1 year until next milestone

Study Start

First participant enrolled

March 31, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Completed
Last Updated

August 4, 2026

Status Verified

July 1, 2026

Enrollment Period

4 months

First QC Date

March 19, 2025

Last Update Submit

August 3, 2026

Conditions

Weight LossObesity and Obesity-related Medical Conditions

Outcome Measures

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.

    TBWL assessed at five-years post ESG

Interventions

No Intervention: Observational CohortOTHER

No Intervention, Observational Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study participants will be selected from weight loss or bariatric centers

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Endeavor Health Evanston Hospital

Evanston, Illinois, 60201, United States

Location

The University of Texas Health Science Center at Houston

Bellaire, Texas, 77401, United States

Location

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2025

First Posted

March 25, 2025

Study Start

March 31, 2026

Primary Completion

July 30, 2026

Study Completion

July 30, 2026

Last Updated

August 4, 2026

Record last verified: 2026-07

Locations

US(2)