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BIO-SEE: Bioburden Imaging Outcome Study for Equivalence Evaluation
Sponsor: Capsicure, LLC
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.
Official title: Confirmatory Study of Substantial Equivalence Between cureVision cV and MolecuLight i:X in Detecting Bacterial Burden in Wounds
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-05-01
Completion Date
2026-10-01
Last Updated
2026-05-28
Healthy Volunteers
Yes
Interventions
cureVision cV
combination of CSS and fluorescence imaging with cureVision cV system
Locations (5)
North Park Podiatry, Foot and Ankle Surgery
San Diego, California, United States
Solutions Medical Research
Coral Gables, Florida, United States
NAR Medical Research Group
Miami, Florida, United States
NOVA Medical Research
Miami, Florida, United States
Halo Clinical Research
Houston, Texas, United States