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.
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.
Study Type
OBSERVATIONAL
Enrollment
75
510(k) summary K081853 dated June 26, 2008, Endoscopic Sleeve Gastroplasty lecture, Methodist Dallas Medical Center Endobariatric Pathway \& Endoscopic Sleeve Gastroplasty Procedure Description
Methodist Dallas Medical Center
Dallas, Texas, United States
Weight loss
Percentage of total and excess weight loss at 30 days, 3 months, 6 months and 12 months after procedure.
Time frame: 8/1/2018 and 8/1/2023
Documentation of safety
procedure readmission rate (in days)
Time frame: 8/1/2018 and 8/1/2023
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.