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CompuFlo CathCheck

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion dates: Dec 31, 2025 to Dec 31, 2026v5
  2. Primary completion date: Sep 30, 2026 to Dec 31, 2025
    • Study completion date: Mar 31, 2027 to Dec 31, 2025
    v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 3, 2024 to Sep 30, 2024
    v3
  4. Start date: Jun 3, 2024 to Sep 3, 2024
    • Primary completion date: Jun 30, 2026 to Sep 30, 2026
    • Study completion date: Dec 31, 2026 to Mar 31, 2027
    v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 purpose of this study is to determine if the Compuflo CathCheck system is equivalent to an epidurogram in determining epidural catheter location (in or outside the epidural space), using the epidurogram as the gold standard. In short, this will be completed by performing an epidurogram (as is standard of practice and the gold standard of determining epidural placement) and compare it to the results of the Compuflo CathCheck system. Equivalency will be summarized through agreement and concordance. Additionally, secondary outcomes will look at how classical physical exam findings to confirm epidural placement correlate and compare to epidurogram and Compuflo CathCheck findings.
Trial Details
NCT Number NCT06460155
Lead Sponsor University of Minnesota
Conditions
(from sponsor)		 Epidural Placement
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov