BIO-SEE: Bioburden Imaging Outcome Study for Equivalence Evaluation

NCT07611318 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: BIO-SEE
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 5

Brief 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 market.

Conditions

DFU; VLU; Surgical Wound; Wounds; Pressure Injuries

Outcome Measures

Primary Outcomes (1)

• 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

  Day 1

Secondary Outcomes (1)

• To evaluate the safety of the cureVision cVdevice during clinical use

  Day 1

Study Arms (1)

cureVision cV

ACTIVE COMPARATOR

combination of CSS and fluorescence imaging with cureVision cV system

Diagnostic Test: cureVision cV

Interventions

cureVision cV DIAGNOSTIC_TEST

combination of CSS and fluorescence imaging with cureVision cV system

cureVision cV

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Capsicure, LLC: lead
• BioLab Holdings: collaborator

Study Sites (5)

North Park Podiatry, Foot and Ankle Surgery

San Diego, California, 92104, United States

Location

Solutions Medical Research

Coral Gables, Florida, 33134, United States

Location

NAR Medical Research Group

Miami, Florida, 33135, United States

Location

NOVA Medical Research

Miami, Florida, 33176, United States

Location

Halo Clinical Research

Houston, Texas, 77035, United States

Location

MeSH Terms

Conditions

Surgical Wound; Wounds and Injuries; Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: May 28, 2026
• Study Start: June 10, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)