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BIO-SEE: Bioburden Imaging Outcome Study for Equivalence Evaluation

StatusEnrolling by Invitation
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 11, 2026 (before its estimated August 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status changed: Not Yet Recruiting → Enrolling by Invitation
    • Primary completion moved earlier from Oct 1, 2026 to Aug 1, 2026
    • Start date changed from estimate of May 1, 2026 to Jun 10, 2026
    • Site contacts updated at 5 of 5 sites
    v2
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study aims to demonstrate the substantial equivalence of the cureVision cV system's performance in detecting moderate to high bacterial loads in direct comparison to the comparator device for fluorescence imaging in wounds, the MolecuLight i:X , to be able to offer the complete cureVision cV system to the US market.
Trial Details
NCT Number NCT07611318
Lead Sponsor Capsicure, LLC
Collaborators: BioLab Holdings
Conditions
(from sponsor)		 DFU, VLU, Surgical Wound, Wounds, Pressure Injuries
Related terms Pressure Ulcer, Surgical Wound, Wounds and Injuries
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov