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RECRUITING
NCT06670638

Development of a Novel Endoscopic Index and Patient-reported Outcome Measure for Clinical Trials in Participants With Permanent Ileostomy

Sponsor: Alimentiv Inc.

View on ClinicalTrials.gov

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