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ENROLLING BY INVITATION
NCT06793423
NA

TruScore Standalone Clinical Study

Sponsor: VeriSkin, Inc.

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to evaluate if the TruScore device can accurately diagnose suspicious skin lesions in patients aged 22 years and older. The main questions it aims to answer are: Can the TruScore device accurately identify non-pigmented skin lesions suggestive of basal cell carcinoma and squamous cell carcinoma? Can the TruScore device accurately identify pigmented skin lesions suggestive of melanoma? Researchers will compare the device's performance on pigmented and non-pigmented lesions to see if it meets the sensitivity and specificity targets. Participants will: Have their suspicious skin lesions evaluated using the TruScore device. Undergo a biopsy of the evaluated lesions for comparison and confirmation by dermatopathologists. Provide demographic and medical history information. The TruScore device works by detecting and analyzing differences in blood flow between normal and malignant skin lesions. It uses a non-invasive, hand-held unit that applies slight pressure to the skin and uses light to measure these differences. The device then provides a recommendation on whether the lesion should be monitored or investigated further by a dermatologist. This study aims to improve the early detection of skin cancer by providing a reliable tool for non-specialist healthcare providers.

Official title: Non-Significant Risk (NSR) Device Study to Evaluate Device Performance on Pigmented, Non-/Pigmented Skin Lesions and Histological Diagnoses: TruScore Standalone Clinical Study

Key Details

Gender

All

Age Range

22 Years - Any

Study Type

INTERVENTIONAL

Enrollment

464

Start Date

2025-09-25

Completion Date

2027-12-30

Last Updated

2026-10-27

Healthy Volunteers

No

Interventions

DEVICE

Skin lesion diagnostic device evaluation

TruScore Device Evaluation for Skin Cancer Diagnosis

Locations (6)

Golden State Dermatology

Pleasanton, California, United States

Golden State Dermatology

Walnut Creek, California, United States

James A Haley Veterans Hospital

Tampa, Florida, United States

John Hopkins Health Care & Surgery Center - Green Spring Station, Lutherville

Lutherville, Maryland, United States

VA Boston Healthcare System

Boston, Massachusetts, United States

Penn Dermatology

Philadelphia, Pennsylvania, United States