Endoscopic Sleeve Gastroplasty / Endoscopic Sleeve Gastroplasty

Obesity Clinical Trial

Official title:

Endoscopic Sleeve Gastroplasty / Endoscopic Sleeve Gastroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04640688
• Other study ID #: 047.GID.2018.D
• Status: Recruiting
• Start date: August 27, 2018
• Est. completion date: August 1, 2024

Study information

• Verified date: July 2023
• Source: Methodist Health System
• Contact: Crystee Cooper, DHEd
• Phone: 214-947-1280
• Email: clinicalresearch[@]mhd.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

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

Locations

Country	Name	City	State
United States	Methodist Dallas Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss	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	Documentation of safety	procedure readmission rate (in days)	8/1/2018 and 8/1/2023