TruScore Standalone Clinical Study

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 Statistical Analysis Phase: In this phase, the collected data is analyzed to determine how well the device performs in identifying cancerous lesions. Participants The study includes patients aged 22 and older who have skin lesions that look suspicious. To participate, patients must meet certain criteria, such as having lesions that are at least 4 mm in diameter. Some patients are excluded from the study, such as those with lesions in hard-to-measure areas or those with certain medical conditions. Device Usage The TruScore device is used on lesions that have already been assessed as suspicious by a healthcare provider. It is not intended to be used as a general screening tool. The device helps doctors decide whether a lesion should be referred to a dermatologist for further evaluation. It provides an additional piece of information to help make this decision but should not be the sole basis for diagnosing skin cancer. The primary objective is to demonstrate the accuracy of the TruScore device. The study aims to achieve specific sensitivity and specificity targets for both pigmented (colored) and non-pigmented (non-colored) lesions. Sensitivity refers to the device's ability to correctly identify cancerous lesions, while specificity refers to its ability to correctly identify non-cancerous lesions. Secondary objectives include evaluating the device's performance across different patient subgroups and assessing any adverse events related to the device's use. The device is considered low-risk because it is non-invasive and does not sustain life or directly diagnose or treat disease. Detection Mechanism The TruScore device detects and analyzes structural and functional vascular abnormalities associated with cancer-induced pathological angiogenesis. Angiogenesis is the formation of new blood vessels, which is a well-established early marker of cancer. The device uses a proprietary technology to detect and analyze force-induced hemodynamic differences between normal and malignant skin lesions. Pressure Application: The device applies slight to moderate pressure (0.2-0.5 pounds) to the skin for several seconds. This pressure causes local blanching of the skin due to temporary loss of blood from the immediate area. The pressure is similar to that applied by a fingertip and is below levels that would cause discomfort or pain. Hemodynamic Analysis: The device measures the hemodynamic response (blood flow changes) induced by the applied pressure. Malignant lesions exhibit different hemodynamic responses compared to normal or benign lesions due to the abnormal blood vessel formation associated with cancer. Data Processing and Output AI Algorithm: The device uses a proprietary AI algorithm to analyze the collected data. The algorithm differentiates between malignant and benign lesions by evaluating the hemodynamic differences. User Interface: The device has a touch screen where the user selects the type of lesion (pigmented or non-pigmented) and the age of the patient. The device provides a specific text output, either "Monitor" (suggesting ongoing monitoring) or "Investigate Further" (indicating the need for referral to a dermatologist). Safety Features Material and Design: The probe head is made of inert plastics and stainless steel, minimizing the risk of contact dermatitis or skin trauma. The device is designed to limit the travel of the probe head to prevent over-application of pressure. Electrical Safety: The device operates on a 4.2 V Li-Ion battery with internal voltages up to 12 V. Only plastic parts come into contact with the skin, ensuring electrical safety. The VerSkin TruScore Standalone Clinical Study is a significant step towards improving the early detection of skin cancer. By testing the TruScore device, the study aims to provide a valuable tool for non-specialist healthcare providers, helping them make better decisions about referring patients to dermatologists. This could lead to earlier detection and treatment of skin cancer, ultimately improving patient outcomes.