RecruitingNot ApplicableNCT05739162

A Study of Endoscopic Sleeve Gastroplasty for Obesity in Ulcerative Colitis

Endoscopic Sleeve Gastroplasty (ESG) as a Treatment Option for Obesity in Ulcerative Colitis (UC) Patients Undergoing Colectomy With Ileal Pouch Anal Anastomosis (IPAA)


Sponsor

Mayo Clinic

Enrollment

12 participants

Start Date

Sep 20, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 22 YearsMax Age: 69 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a non-surgical weight loss procedure called endoscopic sleeve gastroplasty (ESG) — where a doctor uses an endoscope (a flexible tube through the mouth) to stitch the stomach into a smaller sleeve shape — is safe and effective for people with obesity who also have ulcerative colitis (UC) and are planning certain bowel surgery. **You may be eligible if...** - Your BMI is between 30 and 50 kg/m² for at least 6 months - You have been diagnosed with ulcerative colitis and are planning or have already had a colectomy (colon removal) as part of a multi-stage bowel reconstruction - You are willing to follow the required diet and behavior changes - If female, you are not pregnant and are using contraception or are post-menopausal **You may NOT be eligible if...** - You have previously had bariatric (weight loss) surgery or other stomach surgery - You have a gastric or duodenal ulcer, esophageal varices, or large hiatal hernia with severe reflux - You have serious clotting problems, liver failure, or cirrhosis - You have uncontrolled psychiatric illness Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEApollo 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.

BEHAVIORALLifestyle 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.


Locations(1)

Mayo Clinic Minnesota

Rochester, Minnesota, United States

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NCT05739162


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