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

NCT06670638 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2025-11-12

No results posted yet for this study

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.

Conditions

  • Crohns Disease

Sponsors & Collaborators

  • University of Western Ontario, Canada

    collaborator OTHER

  • The Leona M. and Harry B. Helmsley Charitable Trust

    collaborator OTHER

  • The Cleveland Clinic

    collaborator OTHER

  • OPEN Health (Pharmerit)

    collaborator UNKNOWN

  • Alimentiv Inc.

    lead OTHER

Principal Investigators

  • Florian Rieder · The Cleveland Clinic

  • Vipul Jairath · Western University, Canada

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-19
Primary Completion
2026-06-30
Completion
2027-02-28

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06670638 on ClinicalTrials.gov