DFUNCT07611318
BIO-SEE: Bioburden Imaging Outcome Study for Equivalence Evaluation
A study testing cureVision cV in people with DFU and VLU, run by Capsicure, LLC at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- DFU, VLU, Surgical Wound
- What is being tested?
- cureVision cV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 5 sitesUnited States
- Study dates
- 10 Jun 2026to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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).
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites
Solutions Medical Research
Coral Gables, Florida, 33134
Halo Clinical Research
Houston, Texas, 77035
NAR Medical Research Group
Miami, Florida, 33135
NOVA Medical Research
Miami, Florida, 33176
North Park Podiatry, Foot and Ankle Surgery
San Diego, California, 92104
About this study
Official title: Confirmatory Study of Substantial Equivalence Between cureVision cV and MolecuLight i:X in Detecting Bacterial Burden in Wounds
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.
- Conditions
- DFU, VLU, Surgical Wound, Wounds, Pressure Injuries
- Being tested
- cureVision cV
- Medical subject headings
- Surgical Wound, Wounds and Injuries, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cureVision cVDiagnostic test
combination of CSS and fluorescence imaging with cureVision cV system
| Study group | Role | What they receive |
|---|---|---|
| cureVision cV | Active comparator | combination of CSS and fluorescence imaging with cureVision cV system Receives: Diagnostic Test: cureVision cV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
Secondary outcomes (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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start10 Jun 2026
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DFUStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capsicure, LLC
- Sponsor type
- Research network
- Collaborators
- BioLab Holdings
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07611318
- Sponsor's protocol ID
- BIO-SEE
- Status last verified
- Jun 2026
- First submitted
- 10 Apr 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confirmatory Study of Substantial Equivalence Between cureVision cV and MolecuLight i:X in Detecting Bacterial Burden in Wounds
- ClinicalTrials.gov ID
- NCT07611318
- Acronym / sponsor ID
- BIO-SEE
- Conditions
- DFU, VLU, Surgical Wound, Wounds, Pressure Injuries
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Capsicure, LLCResearch network
- Collaborators
- BioLab Holdings
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cureVision cV | Active comparator | Diagnostic Test: cureVision cVcombination of CSS and fluorescence imaging with cureVision cV system |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cureVision cVcombination of CSS and fluorescence imaging with cureVision cV system | Diagnostic test | cureVision cV |
Primary outcome
Estimate the agreement between cureVision cV and MolecuLight i:X in the detection of moderate-to-high bacterial loads
Time frame: 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
1 secondary outcome
To evaluate the safety of the cureVision cVdevice during clinical use
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cureVision cV in people with DFU and VLU, run by Capsicure, LLC at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimate the agreement between cureVision cV and MolecuLight i:X in the detection of moderate-to-high bacterial loads (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.