U.S., May 29 -- ClinicalTrials.gov registry received information related to the study (NCT07611318) titled 'BIO-SEE: Bioburden Imaging Outcome Study for Equivalence Evaluation' on April 10.
Brief 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.
Study Start Date: May 01
Study Type: INTERVENTIONAL
Condition:
DFU
VLU
Surgical Wound
Wounds
Pressure Injuries
Intervention:
DIAGNOSTIC_TEST: cureVision cV
combination of CSS and fluorescence imaging with cureVision...