Endoscopic Sleeve Gastroplasty / Endoscopic Sleeve Gastroplasty

Sponsor

Methodist Health System (Other)

Overall Status

Recruiting

CT.gov ID

NCT04640688

Collaborator

(none)

Enrollment

Location

59.1

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Procedure: Bariatric procedures

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

50 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Endoscopic Sleeve Gastroplasty / Endoscopic Sleeve Gastroplasty

Actual Study Start Date :

Aug 27, 2018

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Outcome Measures

Primary Outcome Measures

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

Documentation of safety [8/1/2018 and 8/1/2023]
procedure readmission rate (in days)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Methodist Dallas Medical Center	Dallas	Texas	United States	75023

Sponsors and Collaborators

Methodist Health System

Investigators

Principal Investigator: Prashant Kedia, MD, Methodist Dallas Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Methodist Health System

ClinicalTrials.gov Identifier:

NCT04640688

Other Study ID Numbers:

047.GID.2018.D

First Posted:

Nov 23, 2020

Last Update Posted:

Dec 13, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Dec 13, 2021