VeriSkin, Inc.
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.
The VerSkin TruScore Standalone Clinical Study is an important research project aimed at testing a new medical device called TruScore. This device is designed to help doctors, especially those who are not skin specialists, determine if a suspicious skin lesion might be cancerous and needs further examination by a dermatologist. Study Design The study is conducted in multiple locations and involves two main phases: Data Collection Phase: In this phase, data is collected from patients who have suspicious skin lesions. The TruScore device is used to evaluate these lesions. Data and Statistica…
Inclusion Criteria: * Age: Participants must be 22 years or older. * Lesion Characteristics: Participants must have primary skin lesions (i.e., not metastases or recurrent lesions) that are identified as suspicious by the patient or chosen for biopsy by non-dermatologist clinicians. * Lesion Size: The skin lesion must be 4 mm in diameter or greater. * Multiple Lesions: If a participant has multiple skin lesions, all lesions to be biopsied will be identified as individual skin lesions for the study. A maximum of three skin lesions may be measured per participant. * Informed Consent: Participan…
TruScore Device Evaluation for Skin Cancer Diagnosis