A Study of Endoscopic Sleeve Gastroplasty for Obesity in Ulcerative Colitis
NCT05739162 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2025-12-01
Summary
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.
Conditions
Interventions
- DEVICE
-
Apollo Endoscopic Suture System
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.
- BEHAVIORAL
-
Lifestyle Intervention
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.
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Amanda M Johnson, MD · Mayo Clinic
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 22 Years
- Max Age
- 69 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-09-20
- Primary Completion
- 2026-06-30
- Completion
- 2027-01-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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