TRENCH 1NCT05903066
TRansmural hEaliNg Definition in CroHn's Disease (TRENCH 1)
StatusCompleted
PhaseNot specified
Primary completion
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Record History
All 4 versions: 4 with changes below. See every version on ClinicalTrials.gov ↗
Notable Eligibility criteria expanded, about 17 words Show 5 more changesShow less
- Trial completed
- Trial sites reduced: 18 → 13 locations
- Final enrollment: 320 participants (planned 210)
- Primary completion date changed from estimate of Jul 2025 to Sep 19, 2025
- Study description expanded, about 2 words
- Minor Start date: Oct 11, 2023 to Sep 28, 2023v3
Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
- Primary completion date: Mar 2025 to Jul 2025
- Study completion date: Mar 2025 to Aug 2025
- Start date changed from estimate of Jul 2023 to Oct 11, 2023
- Site details revised at 18 of 18 sites
- Study First Submitted
- Notable: the plan changed
- Minor: routine updates
Endpoints
Primary
Objective definition of depth or grade of transmural healing in relation to radiologic signs observed during Magnetic Resonance Enterography (MRE) in CD
Timeframe: Day 1
Secondary (2)
Intra- and inter-observer variability of lesions observed per segment during MRE in CD
Intra- and inter-observer variability of depth and grade of global transmural healing in CD
Arms and interventions
Procedures: Magnetic Resonance Enterography (MRE)
Sites
13 sites in 2 countries
France 12, Belgium 1