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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: Recruiting study of Crohn's Disease, sponsored by Alimentiv.
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 2,394-participant average among 105 other Crohn's Disease trials with a reported enrollment target (98% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Concept elicitation interviews focusing on the symptoms and impacts relevant to patients with CD and permanent ileostomy will be conducted and used to develop a PRO. Cognitive interviews will subsequently be conducted to determine respondent comprehension and relevance of the items.
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 |
What NCT06670638 shows while recruiting
NCT06670638 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 2,394-participant average among 105 other Crohn's Disease trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 0 interventions.
NCT06670638 lists 5 locations in 4 states (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.
Learn More About Clinical Trials
Similar trials for Crohn's Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06670638's enrollment target sits among peer trials
50 82nd of 105 higher than 24 of 105 other Crohn's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn's Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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