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New wound scanner aims to spot hidden bacteria

NCT ID NCT07611318

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

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

22 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. 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.

    Open the record ↗

  3. 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

  • Halo Clinical Research

    Houston, Texas, 77035, United States

  • NAR Medical Research Group

    Miami, Florida, 33135, United States

  • NOVA Medical Research

    Miami, Florida, 33176, United States

  • North Park Podiatry, Foot and Ankle Surgery

    San Diego, California, 92104, United States

  • Solutions Medical Research

    Coral Gables, Florida, 33134, United States

More trials for these conditions

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