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BIO-SEE: Evaluating cureVision cV for Wound Bacteria Detection

This study is testing a new device called cureVision cV. It uses a combination of light and imaging to find moderate-to-high levels of bacteria in wounds. Researchers want to see if cureVision cV works as well as another device already on the market, MolecuLight i:X, for detecting these bacteria. The goal is to make cureVision cV available in the US. You might be able to join if you are at least 22 years old and have certain types of wounds, like diabetic foot ulcers (DFUs), venous leg ulcers (VLUs), pressure injuries, or open surgical wounds. The study is currently unclear on its recruitment status and plans to enroll 100 people.

Study design
This interventional study aims to enroll 100 participants. It compares the cureVision cV system to the MolecuLight i:X device.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is to assess agreement in bacterial detection at Day 1.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07611318

BIO-SEE: Bioburden Imaging Outcome Study for Equivalence Evaluation

Enrolling by Invitation
NAAges 22+InterventionalDiagnostic
Capsicure, LLC
~100 participants
Updated 2026-06-11 on ClinicalTrials.gov
What's tested:cureVision cV

At a glance

Recruiting sites
0 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Estimate the agreement between cureVision cV and MolecuLight i:X in the detection of moderate-to-high bacterial loads
Measured over Day 1

Conditions

DFU
VLU
Surgical Wound
Wounds
Pressure Injuries

Explore related trials

Diabetic foot ulcerPressure SoreStasis ulcerSurgical woundWound

Where it's being run

5 sites across 3 states
Florida3
California1
Texas1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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:
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

The target wound cannot be completely imaged by the comparator device due to anatomical location, such as wounds that are:
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).

What this trial measures

  • Estimate the agreement between cureVision cV and MolecuLight i:X in the detection of moderate-to-high bacterial loadsDay 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