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A Study of Endoscopic Sleeve Gastroplasty for Obesity in Ulcerative Colitis

Primary Purpose

Obesity, Ulcerative Colitis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Apollo Endoscopic Suture System
Lifestyle Intervention
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring ESG, IPAA

Eligibility Criteria

22 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 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: 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 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

Sites / Locations

  • Mayo Clinic MinnesotaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Endoscopic Sleeve Gastroplasty (ESG)

Diet and Exercise

Arm Description

Participants undergo Endoscopic Sleeve Gastroplasty (ESG). Following the 6-week transitional diet after undergoing the ESG procedure, participants will start the lifestyle intervention.

Participants receive lifestyle intervention only for 24 months

Outcomes

Primary Outcome Measures

Percent total body weight loss
Percent total body weight loss (%TBWL) calculated by the equation ((visit 3 weight in kilograms (kg) subtracted by randomization weight in kg) divided by randomization weight in kg) times 100.
Number of subjects with serious adverse events
Total number of subjects to report serious adverse event related to the ESG procedure

Secondary Outcome Measures

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
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
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."
Pouchitis disease activity index (PDAI)
Assess overall pouch function one year following ileostomy takedown using the pouchitis disease activity index (PDAI) score. The PDAI quantitates clinical symptoms and endoscopic and histological features (acute histological inflammation: crypt abscess and ulceration) on three separate six-point scores, whereby a total score higher than 7 is indicative of pouchitis.
Durable weight loss
Number of subjects to achieve durable weight loss

Full Information

First Posted
February 13, 2023
Last Updated
October 18, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05739162
Brief Title
A Study of Endoscopic Sleeve Gastroplasty for Obesity in Ulcerative Colitis
Official Title
Endoscopic Sleeve Gastroplasty (ESG) as a Treatment Option for Obesity in Ulcerative Colitis (UC) Patients Undergoing Colectomy With Ileal Pouch Anal Anastomosis (IPAA)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2023 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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 ulcerative colitis (UC) patients undergoing colectomy with eventual Ileal Pouch Anal Anastomosis (IPAA) compared to counseling on diet and lifestyle interventions alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Ulcerative Colitis
Keywords
ESG, IPAA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endoscopic Sleeve Gastroplasty (ESG)
Arm Type
Experimental
Arm Description
Participants undergo Endoscopic Sleeve Gastroplasty (ESG). Following the 6-week transitional diet after undergoing the ESG procedure, participants will start the lifestyle intervention.
Arm Title
Diet and Exercise
Arm Type
Active Comparator
Arm Description
Participants receive lifestyle intervention only for 24 months
Intervention Type
Device
Intervention Name(s)
Apollo Endoscopic Suture System
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent total body weight loss
Description
Percent total body weight loss (%TBWL) calculated by the equation ((visit 3 weight in kilograms (kg) subtracted by randomization weight in kg) divided by randomization weight in kg) times 100.
Time Frame
6 months
Title
Number of subjects with serious adverse events
Description
Total number of subjects to report serious adverse event related to the ESG procedure
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Number of early peri-operative complications
Description
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 procedure
Title
Number of late peri-operative complications
Description
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 procedure
Title
Change gastrointestinal symptom rating scale (GSRS)
Description
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 takedown
Title
Pouchitis disease activity index (PDAI)
Description
Assess overall pouch function one year following ileostomy takedown using the pouchitis disease activity index (PDAI) score. The PDAI quantitates clinical symptoms and endoscopic and histological features (acute histological inflammation: crypt abscess and ulceration) on three separate six-point scores, whereby a total score higher than 7 is indicative of pouchitis.
Time Frame
12 months post-ileostomy takedown
Title
Durable weight loss
Description
Number of subjects to achieve durable weight loss
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ESG with IPAA Study Team
Phone
507-538-8238
Email
DLRSTIPAAinfo@mayo.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Abigail A Stromme
Phone
507-538-8238
Email
stromme.abigail@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda M Johnson, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Minnesota
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abigail A Stromme
Phone
507-538-8238
Email
stromme.abigail@mayo.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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A Study of Endoscopic Sleeve Gastroplasty for Obesity in Ulcerative Colitis

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