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TruScore Standalone Clinical Study
Sponsor: VeriSkin, Inc.
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
Conditions
Interventions
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