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RECRUITING

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

NCT06670638 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 50 participants
Start Date 2024-06-19
Est. Completion 2027-02-28

Sponsor

Alimentiv

32 total trials

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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. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alimentiv, which has 32 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Crohns Disease appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06670638 reports 5 study locations spanning 4 distinct geographic areas — top geographies include Ontario, Minnesota, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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: Crohns Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

Who is sponsoring clinical trial NCT06670638?

This trial is sponsored by Alimentiv, which has 32 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial