Clinical Trial

BIO-SEE: Bioburden Imaging Outcome Study for Equivalence Evaluation

Enrolling by Invitation
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.
Summary
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.
Protocol Amendment History 2 changes
critical Trial status changed: Not Yet Recruiting → Enrolling by Invitation 2026-06-12
notable Primary completion moved earlier: 2026-10-01 -> 2026-08-01 2026-06-12
Trial Details
NCT Number NCT07611318
Lead Sponsor Capsicure, LLC
Collaborators: BioLab Holdings
Conditions DFU, VLU, Surgical Wound, Wounds, Pressure Injuries
Enrollment 100 participants
Start Date 2026-06-10
Primary Completion 2026-08-01 (estimated)
Study Completion 2026-10-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-11