NCT04640688

Endoscopic Sleeve Gastroplasty / Endoscopic Sleeve Gastroplasty

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 75 (actual)
• Sponsor: Methodist Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity

Interventions

Type	Name	Description
PROCEDURE	Bariatric procedures	510(k) summary K081853 dated June 26, 2008, Endoscopic Sleeve Gastroplasty lecture, Methodist Dallas Medical Center Endobariatric Pathway \& Endoscopic Sleeve Gastroplasty Procedure Description

Timeline

• Start date: 2018-08-27
• Primary completion: 2026-02-09
• Completion: 2026-03-09
• First posted: 2020-11-23
• Last updated: 2026-03-23

Locations

1 site across 1 country: United States