An interventional study of cureVision cV in DFU, VLU and Surgical Wound, sponsored by Capsicure, LLC. Enrolling by invitation at 5 sites in United States. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by Capsicure, LLC · Not applicable, Interventional, and Diagnostic
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.
315 studies on the registry are indexed under Surgical Wound; 57 are open to participants now.
This study's planned enrollment of 100 is above the median of 66 across 242 interventional studies indexed under Surgical Wound.
Browse Surgical Wound studies →Capsicure, LLC is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Complete imaging using the device, and collection of tissue 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.
Exclusion Criteria:
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).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
combination of CSS and fluorescence imaging with cureVision cV system
Diagnostic Test: cureVision cV
combination of CSS and fluorescence imaging with cureVision cV system
Estimate the agreement between cureVision cV and MolecuLight i:X in the detection of moderate-to-high bacterial loads
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
Time frame: Day 1
To evaluate the safety of the cureVision cVdevice during clinical use
Number of patients with treatment related adverse events as assessed by CTCAR v4.0 compared to predicate device.
Time frame: Day 1
Plan to share: No — The final study results will be shared, but not individual patient data or anything that can be used to identify a subject in any way.
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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