New wound scanner aims to spot hidden bacteria
NCT ID NCT07611318
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares a new device, cureVision cV, to an existing one (MolecuLight i:X) to see if it can accurately detect moderate to high levels of bacteria in wounds. About 100 adults with various wound types (like diabetic foot ulcers or surgical wounds) will be enrolled. The goal is to show the new device works just as well, so it can be sold in the US.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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22 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Halo Clinical Research
Houston, Texas, 77035, United States
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NAR Medical Research Group
Miami, Florida, 33135, United States
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NOVA Medical Research
Miami, Florida, 33176, United States
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North Park Podiatry, Foot and Ankle Surgery
San Diego, California, 92104, United States
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Solutions Medical Research
Coral Gables, Florida, 33134, United States
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