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Development of a Novel Endoscopic Index and Patient-reported Outcome Measure for Clinical Trials in Participants With Permanent Ileostomy
Sponsor: Alimentiv Inc.
Summary
To date, patients with Crohn's Disease (CD) and permanent ileostomies have been excluded from clinical trials for new treatments. To allow this patient population to be included in clinical trials, outcome and measurement tools are needed. This study aims to develop a Patient Reported Outcome (PRO) and Endoscopic Index (EI) for patients with Crohn's Disease (CD) and permanent ileostomy. The study will enroll about 50 participants and collect videos of endoscopies that are done as part of standard of care. The videos will be centrally read to identify features that represent a broad range of inflammation and will be used to develop the EI. Participants will also be asked to participate in interviews, to understand the symptoms and impacts that are most important to participants for the development of a PRO.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
50
Start Date
2024-06-19
Completion Date
2027-02-28
Last Updated
2025-11-12
Healthy Volunteers
No
Conditions
Locations (5)
Mayo Clinic- Rochester
Rochester, Minnesota, United States
Washington University in St Louis School of Medicine
St Louis, Missouri, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
McMaster University Medical Centre
Hamilton, Ontario, Canada
LHSC - University Campus
London, Ontario, Canada