Endoscopic Sleeve Gastroplasty / Endoscopic Sleeve Gastroplasty

NCT04640688 | Completed

• 1 other identifier: 047.GID.2018.D
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Documentation of safety

  8/1/2018 and 8/1/2023

Interventions

Bariatric procedures PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients who undergo bariatric procedures at Methodist Dallas Medical Center

You may qualify if:

• 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

You may not qualify if:

• Below 18 years of age
• Prohibitive anesthetic risk

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75023, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• Prashant Kedia, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: November 23, 2020
• Study Start: August 27, 2018
• Primary Completion: February 9, 2026
• Study Completion: March 9, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)