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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Alimentiv Inc.
Study ID
NCT06670638
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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 Dates

Start date
Jun 19, 2024
Status verified
Nov 2025
Primary completion
Jun 30, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
50 participants (estimated)

Primary Outcome Measure

Develop a PRO instrument for patients with Crohn's Disease and Permanent Ileostomy [ Time Frame: through study completion, and average of 1 year ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Mayo Clinic- RochesterRochesterMinnesota55905
David Bruning (PRINCIPAL_INVESTIGATOR)
Washington University in St Louis School of MedicineSt LouisMissouri63110
Parakkal Deepak (PRINCIPAL_INVESTIGATOR)
Cleveland Clinic FoundationClevelandOhio44195
Catherine Larson
[email protected]
Florian Rieder (PRINCIPAL_INVESTIGATOR)

Find similar trials in Rochester, MN

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Mayo Clinic- Rochester· Rochester, MNWashington University in St Louis School of Medicine· St Louis, MOCleveland Clinic Foundation· Cleveland, OH

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