BIO-SEE: Bioburden Imaging Outcome Study for Equivalence Evaluation

Part of paid clinical trials in San Diego, California.

Sponsor
Capsicure, LLC
Study ID
NCT07611318
Status
Enrolling By Invitation

Conditions

  • DFU
  • Pressure Injuries
  • Surgical Wound
  • VLU
  • Wounds

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • cureVision cV — DIAGNOSTIC_TEST
    combination of CSS and fluorescence imaging with cureVision cV system

Study Details

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.

Key Dates

Start date
Jun 10, 2026
Status verified
Jun 2026
Primary completion
Aug 1, 2026
Completion
Oct 1, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: cureVision cV
    combination of CSS and fluorescence imaging with cureVision cV system

Primary Outcome Measure

Estimate the agreement between cureVision cV and MolecuLight i:X in the detection of moderate-to-high bacterial loads [ Time Frame: Day 1 ]

Locations (5)

FacilityCityStateZIPSite coordinators
North Park Podiatry, Foot and Ankle SurgerySan DiegoCalifornia92104-
Solutions Medical ResearchCoral GablesFlorida33134-
NAR Medical Research GroupMiamiFlorida33135-
NOVA Medical ResearchMiamiFlorida33176-
Halo Clinical ResearchHoustonTexas77035-

Find similar trials in San Diego, CA

By research site
North Park Podiatry, Foot and Ankle Surgery· San Diego, CASolutions Medical Research· Coral Gables, FLNAR Medical Research Group· Miami, FLNOVA Medical Research· Miami, FLHalo Clinical Research· Houston, TX

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