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NOT YET RECRUITING
NCT07611318
NA

BIO-SEE: Bioburden Imaging Outcome Study for Equivalence Evaluation

Sponsor: Capsicure, LLC

View on ClinicalTrials.gov

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.

Official title: Confirmatory Study of Substantial Equivalence Between cureVision cV and MolecuLight i:X in Detecting Bacterial Burden in Wounds

Key Details

Gender

All

Age Range

22 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-05-01

Completion Date

2026-10-01

Last Updated

2026-05-28

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

cureVision cV

combination of CSS and fluorescence imaging with cureVision cV system

Locations (5)

North Park Podiatry, Foot and Ankle Surgery

San Diego, California, United States

Solutions Medical Research

Coral Gables, Florida, United States

NAR Medical Research Group

Miami, Florida, United States

NOVA Medical Research

Miami, Florida, United States

Halo Clinical Research

Houston, Texas, United States