A Study of Endoscopic Sleeve Gastroplasty for Obesity in Ulcerative Colitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-69
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
BMI 30-50 kg/m2 for at least 6 months prior to ESG
Diagnosis of UC with plans to undergo or who have already undergone colectomy as part of a plan to pursue eventual 3-stage ileal pouch anal anastomosis (IPAA)
Willing to adhere to the diet and behavior modifications required for ESG
Able to follow the visit schedule
Disqualifiers
Prior gastric or bariatric surgery or other alteration to upper gastrointestinal anatomy which would preclude safe or technical performance of ESG
Current or recent (last six months) gastric or duodenal ulceration
Esophageal or gastric varices
Significant motility disorder of the esophagus or stomach
Trial design
Design model
Single group
Treatments tested in this trial
Apollo Endoscopic Suture System
DeviceEndoscopic 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.
Lifestyle Intervention
BehavioralLow-calorie healthy diet personalized by a dietician according to individual patients' needs and conducive to weight loss. Physical activity will be encourage and assessed.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Endoscopic Sleeve Gastroplasty (ESG)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
6 months2
Number of subjects with serious adverse events
Total number of subjects to report serious adverse event related to the ESG procedure
Time frame
24 monthsSecondary outcomes
1
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
Time frame
1 year following procedure2
Number of late peri-operative complications
Number of late (greater than 30 days) peri-operative complications related to IPAA and ileostomy takedown clinical standard of care procedure
Time frame
1 year following procedure3
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."
Time frame
Week 4, Week 12, Week 24, 12 months post-ileostomy takedown4
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.
Time frame
12 months post-ileostomy takedownSponsors and contacts
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Source ClinicalTrials.gov