Obesity
Conditions
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.
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.
Interventions
PROCEDUREBariatric procedures
510(k) summary K081853 dated June 26, 2008, Endoscopic Sleeve Gastroplasty lecture, Methodist Dallas Medical Center Endobariatric Pathway \& Endoscopic Sleeve Gastroplasty Procedure Description
Sponsors
Methodist Health System
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Documentation of safety | 8/1/2018 and 8/1/2023 | procedure readmission rate (in days) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPrashant Kedia, MD
The Methodist Hospital Research Institute
Outcome results
None listed