Endoscopic Sleeve Gastroplasty / Endoscopic Sleeve Gastroplasty

Recruiting

• Conditions: Obesity

• Registration Number: NCT04640688
• Lead Sponsor: Methodist Health System

Brief Summary

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.

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 Timeline

• Study Start: 2018-08-27
• Study First Submitted: 2019-08-12
• Study First Submitted QC: 2020-11-18
• Study First Posted: 2020-11-23
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-11
• Last Update Posted: 2023-07-12
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight loss	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.

Secondary Outcome Measures

Name	Time	Method
Documentation of safety	8/1/2018 and 8/1/2023	procedure readmission rate (in days)

Trial Locations

Locations (1)

Methodist Dallas Medical Center; 🇺🇸 Dallas, Texas, United States