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NCT06670638 · ClinicalTrials.gov registry record
Development of a Novel Endoscopic Index and Patient-reported Outcome Measure for Clinical Trials in Participants With Permanent Ileostomy
A clinical trial of Crohn's Disease, sponsored by Alimentiv.
- Recruiting
- Registry status
- 50
- Enrollment target
- 5
- Study locations
NCT06670638 is a study of Crohn's Disease that is actively recruiting participants, run by Alimentiv. The registered enrollment target is 50 participants, below the 2,414-participant average among 104 other Crohn's Disease trials with a reported enrollment target (98% lower). The trial reports 5 study locations across 4 states.
The verdict
NCT06670638, a study of Crohn's Disease, is actively recruiting participants, sponsored by Alimentiv.
- RECRUITING
- Registry status
- 50 participants
- Enrollment target
- 5
- Study locations
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 Studied
Study Locations (5)
Ontario
- McMaster University Medical Centre - Hamilton
- LHSC - University Campus - London
Minnesota
- Mayo Clinic- Rochester - Rochester
Missouri
- Washington University in St Louis School of Medicine - St Louis
Ohio
- Cleveland Clinic Foundation - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2024-06-19 |
| Est. Completion | 2027-02-28 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06670638
The ClinicalTrials.gov registry entry for NCT06670638 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,414-participant average among 104 other Crohn's Disease trials with a reported enrollment target (98% lower). The listed sponsor is Alimentiv, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 0 interventions.
NCT06670638 reports 5 study locations spanning 4 distinct geographic areas - top geographies include Ontario, Minnesota, Missouri.
Frequently Asked Questions
What is clinical trial NCT06670638 about?
NCT06670638 is a clinical study titled "Development of a Novel Endoscopic Index and Patient-reported Outcome Measure for Clinical Trials in Participants With Permanent Ileostomy". 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) ...
What is the current status of trial NCT06670638?
This trial is currently recruiting. The enrollment target is 50 participants. The study started on 2024-06-19. Estimated completion is 2027-02-28.
What conditions does trial NCT06670638 study?
This clinical trial studies the following conditions: Crohn's Disease.
Who is sponsoring clinical trial NCT06670638?
This trial is sponsored by Alimentiv, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06670638 being conducted?
This trial has 5 study locations across Minnesota, Missouri, Ohio, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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