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BIO-SEE: Bioburden Imaging Outcome Study for Equivalence Evaluation

NCT07611318 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-05-28

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

cureVision cV

combination of CSS and fluorescence imaging with cureVision cV system

Sponsors & Collaborators

  • BioLab Holdings

    collaborator INDUSTRY

  • Capsicure, LLC

    lead NETWORK

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2026-10-01
Completion
2026-10-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07611318 on ClinicalTrials.gov