Endoscopic Sleeve Gastroplasty / Endoscopic Sleeve Gastroplasty

March 19, 2026 updated by: Methodist Health System

This will be a prospective, registry study of an investigational procedure for at least 12 standard of care visits up to 1 year after subject consents for study. Subjects will be enrolled between 8/1/2018 and 8/1/2023. Subjects will undergo a clinically indicated endoscopic procedure and subsequent follow up clinic visits as part of their standard medical care.

Disclaimer: To undergo the procedure there is an out of pocket expense for $9000.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All procedures, barring research activities such as consenting and data collection from Electronic Health Record , will be either clinically indicated and/or standard of care. Subject data will be collected and recorded in a registry which will allow for the prospective review and collection of clinical data related to Endoscopic Sleeve Gastroplasty for safety and efficacy assessment.

Study duration: At least 12 standard of care visits up to 1 year for each subject.

Standard of care follow up visits for Endoscopic Sleeve Gastroplasty are usually 2 weeks, 3 months, 6 months and 12 months post procedure with the physician and 8 follow-up visits over the year with a dietitian. No additional research related visits will be requested. All data will be collected from Electronic Health Record.

Disclaimer: To undergo the procedure there is an out of pocket expense for $9000.

Study Type

Observational

Enrollment (Actual)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75023
        • Methodist Dallas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All patients who undergo bariatric procedures at Methodist Dallas Medical Center

Description

Inclusion Criteria:

  • Age 18 years or older
  • Able to comprehend and provided written informed consent
  • Willing to comply with the substantial lifelong dietary restrictions required by the procedure
  • History of failure with non-surgical weight-loss methods
  • Willing to follow protocol requirements, including providing informed consent, routine follow-up schedule, completing laboratory tests, and completing diet counseling
  • Women of childbearing potential ( not post-menopausal or surgically sterilized) must agree to use adequate birth control methods

Exclusion Criteria:

  • Below 18 years of age
  • Prohibitive anesthetic risk

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight loss
Time Frame: 8/1/2018 and 8/1/2023
Percentage of total and excess weight loss at 30 days, 3 months, 6 months and 12 months after procedure.
8/1/2018 and 8/1/2023

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Documentation of safety
Time Frame: 8/1/2018 and 8/1/2023
procedure readmission rate (in days)
8/1/2018 and 8/1/2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Methodist Health System

Investigators

  • Principal Investigator: Prashant Kedia, MD, The Methodist Hospital Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 27, 2018

Primary Completion (Actual)

February 9, 2026

Study Completion (Actual)

March 9, 2026

Study Registration Dates

First Submitted

August 12, 2019

First Submitted That Met QC Criteria

November 18, 2020

First Posted (Actual)

November 23, 2020

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 047.GID.2018.D

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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