Capsicure, LLC
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.
Inclusion Criteria: * Age ≥ 22 years * Eligible wounds include all wound etiologies including but not limited to DFUs, VLUs, pressure injuries, and open postsurgical wounds. * Presence of at least one target wound of sufficient size to allow: Complete imaging using the investigational device, and collection of tissue biopsy samples, as required by the study protocol \- The target wound must be located in an anatomical region that permits: Full visualization, appropriate positioning for imaging, and safe and feasible biopsy sampling. * Written informed consent possible * Wound suitable for…
combination of CSS and fluorescence imaging with cureVision cV system