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The purpose of this research is to gather information on the safety and effectiveness of Endoscopic Sleeve Gastroplasty (ESG) for weight loss in a population of obese UC patients undergoing colectomy with eventual IPAA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic Sleeve Gastroplasty (ESG) | Experimental | Participants undergo Endoscopic Sleeve Gastroplasty (ESG). Following the 6-week transitional diet after undergoing the ESG procedure, participants will start the lifestyle intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apollo Endoscopic Suture System | Device | Endoscopic Sleeve Gastroplasty (ESG), and endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 70-80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent total body weight loss | Percent total body weight loss (%TBWL) calculated by the equation ((baseline screening weight in kilograms (kg) subtracted by follow-up weight in kg) divided by baseline screening weight in kg) times 100. | 6 months |
| Number of subjects with serious adverse events | Total number of subjects to report serious adverse event related to the ESG procedure | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of early peri-operative complications | Number of early (less than 30 days) peri-operative complications related to IPAA and ileostomy takedown clinical standard of care procedure | 1 year following procedure |
| Number of late peri-operative complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amanda M Johnson, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Minnesota | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Lifestyle Intervention | Behavioral | Low-calorie healthy diet personalized by a dietician according to individual patients' needs and conducive to weight loss. Physical activity will be encourage and assessed. |
|
Number of late (greater than 30 days) peri-operative complications related to IPAA and ileostomy takedown clinical standard of care procedure |
| 1 year following procedure |
| Change gastrointestinal symptom rating scale (GSRS) | ESG tolerance measured by GSRS which includes 15 items and utilizes a 7-point response scale to measure a participant's level of discomfort associated with a given GI symptom, ranging from "No discomfort at all" to "Very severe discomfort." | Week 4, Week 12, Week 24, 12 months post-ileostomy takedown |
| Modified pouchitis disease activity index (mPDAI) | Assess overall pouch function one year following ileostomy takedown using the modified pouchitis disease activity index (mPDAI) score. The mPDAI quantitates clinical symptoms and endoscopic features (edema, granularity, friability, loss of vascular pattern, mucus exudate, and ulceration) on several separate 0-2 point scores, whereby a total score greater than or equal to 5 is indicative of pouchitis. | 12 months post-ileostomy takedown |
| Durable weight loss | Number of subjects to achieve durable weight loss | 12 months and 12 months post-ileostomy takedown |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |