Endoscopic Sleeve Gastroplasty / Endoscopic Sleeve Gastroplasty

Study Overview
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Brief Summary
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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
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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.

Official Title
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Endoscopic Sleeve Gastroplasty / Endoscopic Sleeve Gastroplasty

Conditions
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Obesity

Intervention / Treatment
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* Procedure: Bariatric procedures


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Documentation of safety | procedure readmission rate (in days) | 8/1/2018 and 8/1/2023 |