cureVision cV for Wounds
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for people with wounds such as sore throats, diabetic foot ulcers, venous leg ulcers, surgical wounds, nerve injuries, or pressure sores. Participants must have a wound that needs checking for bacteria.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo imaging with the cureVision cV system and MolecuLight i:X to detect bacterial loads
Follow-up
Participants are monitored for safety and effectiveness after imaging
What Are the Treatments Tested in This Trial?
Trial Overview
The study compares the new cureVision cV imaging system to an existing device (MolecuLight i:X) to see if it works just as well at detecting moderate to high levels of bacteria in wounds using special light technology.
How Is the Trial Designed?
1
Treatment groups
Active Control
combination of CSS and fluorescence imaging with cureVision cV system
Find a Clinic Near You
Who Is Running the Clinical Trial?
Capsicure, LLC
Lead Sponsor
BioLab Holdings
Industry Sponsor
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.