A Study of Endoscopic Sleeve Gastroplasty for Obesity in Ulcerative Colitis
NCT ID: NCT05739162
Last Updated: 2025-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
12 participants
INTERVENTIONAL
2023-09-20
2027-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Endoscopic Sleeve Gastroplasty (ESG)
Participants undergo Endoscopic Sleeve Gastroplasty (ESG). Following the 6-week transitional diet after undergoing the ESG procedure, participants will start the lifestyle intervention.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Able to provide informed consent
* If female, be either post-menopausal, surgically sterile, or agree to practice birth control during year of study and have negative serum Human Chorionic Gonadotropin (HCG) at screening/baseline
Exclusion Criteria
* Current or recent (last six months) gastric or duodenal ulceration
* Esophageal or gastric varices
* Significant motility disorder of the esophagus or stomach
* Large hiatal hernia measuring \>5 cm or ≤ 5 cm and associated with severe gastroesophageal reflux
* Severe coagulopathy, hepatic insufficiency, or cirrhosis
* Gastric mass
* Presence of any other medical condition which precludes safe performance of elective endoscopy such as poor general health and/or history of severe hepatic, cardiac, or pulmonary disease
* Serious or uncontrolled psychiatric illness which may compromise patient understanding of procedure or compliance with follow-up visits
* Unwilling to participate in an established diet and behavior modification program, with routine follow-up
* Ongoing corticosteroid use at a dose of \>5 mg daily
* Daily use of anti-inflammatory agents such as non-steroidal medications, or anticoagulants without medical supervision
* Alcohol or drug addiction
* Females who are pregnant, nursing, or planning pregnancy within the next year
* Concomitant use of or unwillingness to avoid any use of weight loss medications, weight loss supplements, or weight loss herbal preparations
* Has a condition or is in a situation which in the investigator's opinion may put the subject at significant risk or may interfere significantly with the subject's participation in the study
22 Years
69 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Amanda M. Johnson
Principal Investigator
Principal Investigators
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Amanda M Johnson, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic Minnesota
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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22-007643
Identifier Type: -
Identifier Source: org_study_id
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