BIO-SEE: Bioburden Imaging Outcome Study for Equivalence Evaluation

May 20, 2026 updated by: Capsicure, LLC

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92104
        • North Park Podiatry, Foot and Ankle Surgery
        • Principal Investigator:
          • Trent Brookshier, DPM
        • Contact:
    • Florida
      • Coral Gables, Florida, United States, 33134
      • Miami, Florida, United States, 33135
        • NAR Medical Research Group
        • Contact:
        • Principal Investigator:
          • Julio L Arronte, MD
      • Miami, Florida, United States, 33176
        • NOVA Medical Research
        • Contact:
        • Principal Investigator:
          • Sandor A Romero, MD
    • Texas
      • Houston, Texas, United States, 77035

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: cureVision cV
combination of CSS and fluorescence imaging with cureVision cV system
Diagnostic test: cureVision cV
combination of CSS and fluorescence imaging with cureVision cV system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the safety of the cureVision cVdevice during clinical use
Time Frame: Day 1
Number of patients with treatment related adverse events as assessed by CTCAR v4.0 compared to predicate device.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Capsicure, LLC

Collaborators

BioLab Holdings

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

April 10, 2026

First Submitted That Met QC Criteria

May 20, 2026

First Posted (Actual)

May 28, 2026

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIO-SEE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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