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Prospective Evaluation of Flare Detection in IBD With Digital Biomarkers: Bring Your Own Device Study

Study acronym: BYOD
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Oct 15, 2027 → Dec 15, 2027
See other at-risk trials from Maastricht University Medical Center

Record History

See every version on ClinicalTrials.gov ↗

  1. Recruitment opened Show 8 more changesShow less
    • Primary endpoints: details revised at 1 of 1 entry
    • Primary and study completion pushed from Oct 15, 2027 to Dec 15, 2027
    • Start date changed from estimate of Jun 15, 2026 to Aug 4, 2026
    • Secondary endpoints: details revised at 4 of 6 entries
    • Site details revised at 3 of 3 sites
    • Collaborators: details revised at 2 of 4 entries
    • Publications: details revised at 7 of 7 entries
    • Eligibility criteria expanded, about 5 words
  2. Re-verified, no change to tracked fieldsv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The aim of this study is to identify HRV changes predictive of IBD flares using patient-own wearable devices in a large cohort supplemented by additional data layers including sleep parameters, step count and clinical data extracted from electronic patient files.
Trial Details
NCT Number NCT07647640
Lead Sponsor Maastricht University Medical Center
Collaborators: Maastricht University, TNO, Franciscus Gasthuis & Vlietland (Hospital), Jeroen Bosch Ziekenhuis, s'-Hertogenbosch
Conditions
(from sponsor)		 Inflammatory Bowel Disease (IBD), Ulcerative Colitis (UC), Crohn Disease (CD)
Related terms Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov