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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Documentation of safety | procedure readmission rate (in days) | 8/1/2018 and 8/1/2023 |
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Inclusion Criteria:
Exclusion Criteria:
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All patients who undergo bariatric procedures at Methodist Dallas Medical Center
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| Name | Affiliation | Role |
|---|---|---|
| Prashant Kedia, MD | The Methodist Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Methodist Dallas Medical Center | Dallas | Texas | 75023 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| ID | Term |
|---|---|
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |