DFU, Pressure Injuries, Surgical Wound, VLU, Wounds
Conditions
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.
Interventions
DIAGNOSTIC_TESTcureVision cV
combination of CSS and fluorescence imaging with cureVision cV system
Sponsors
Capsicure, LLC
BioLab Holdings
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
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 fluorescence imaging under IFU conditions with the study device and the comparator device (e.g., no excessive exudate obscuring visualization
Exclusion criteria
* The target wound cannot be completely imaged by the comparator device due to anatomical location, such as wounds that are: Too extensive to be captured within the device's field of view, positioned on curved, recessed, or otherwise inaccessible regions (e.g., deep sacral clefts, interdigital spaces). * The target wound is too small to support the required biopsy procedures without compromising participant safety or data quality. * Treatment with experimental medication within the last month * Lack of ability to consent * Contraindications for standard wound care or monitoring * Strong therapeutic anticoagulation (e.g., direct oral anticoagulants and warfarin); * Known bleeding diathesis or coagulation disorder that increases risk of biopsy-related complications * Contraindications to local anesthesia or biopsy * Patients with wounds that are not suitable for biopsy, including tunnelling wounds and wounds with fistula formation * Wounds that cannot meet technical imaging requirements (e.g., excessive exudate, severe artifacts, calcification/crust preventing visualization).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimate the agreement between cureVision cV and MolecuLight i:X in the detection of moderate-to-high bacterial loads | Day 1 | The primary objective is to estimate the agreement between cureVision cV and MolecuLight i:X in the detection of moderate-to-high bacterial loads (\>10⁴ CFU/g). Agreement is quantified by Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA), each reported as fractions and percentages with two-sided 95% confidence intervals. As a descriptive benchmark, the study will report whether the lower 95% CI bound for PPA exceeds 0.80 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the safety of the cureVision cVdevice during clinical use | Day 1 | Number of patients with treatment related adverse events as assessed by CTCAR v4.0 compared to predicate device. |
Countries
United States
Outcome results
None listed