Endoscopic Sleeve Gastroplasty / Endoscopic Sleeve Gastroplasty

Phase

N/A

Condition

Obesity

Diabetes Prevention

Treatment

Bariatric procedures

Clinical Study ID

NCT04640688

047.GID.2018.D

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

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 theprocedure
History of failure with non-surgical weight-loss methods
Willing to follow protocol requirements, including providing informed consent, routinefollow-up schedule, completing laboratory tests, and completing diet counseling
Women of childbearing potential ( not post-menopausal or surgically sterilized) mustagree to use adequate birth control methods

Exclusion

Exclusion Criteria:

Below 18 years of age
Prohibitive anesthetic risk

Study Design

Bariatric procedures

August 27, 2018

August 01, 2024

Study 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.