An interventional study of Skin lesion diagnostic device evaluation in Melanoma and Other Malignant Neoplasms of Skin, Basal Cell Carcinoma of Skin and Squamous Cell Carcinoma of the Skin, sponsored by VeriSkin, Inc.. Enrolling by invitation at 6 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by VeriSkin, Inc. · Not applicable, Interventional, and Diagnostic
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 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.
3,370 studies on the registry are indexed under Melanoma; 578 are open to participants now.
This study's planned enrollment of 464 is above the median of 40 across 2,649 interventional studies indexed under Melanoma.
Browse Melanoma studies →This is the only study on the registry with VeriSkin, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Different AI algorithm used for pigmented skin lesions and is selected before doing the skin measurement.
Device: Skin lesion diagnostic device evaluation
Different AI algorithm used for non-pigmented skin lesions and is selected before doing the skin measurement.
Device: Skin lesion diagnostic device evaluation
TruScore Device Evaluation for Skin Cancer Diagnosis
Accuracy of the TruScore device in diagnosing suspicious skin lesions
Measured through 2 main endpoints: Sensitivity: The ability of the TruScore device to correctly identify lesions that are cancerous (true positives). For non-pigmented lesions (e.g., basal cell carcinoma and squamous cell carcinoma), the sensitivity goal is 80% at the lower bound of the two-sided 95% confidence interval. For pigmented lesions (e.g., melanoma), the sensitivity goal is 76.9% at the lower bound of the two-sided 95% confidence interval, with a point estimate of sensitivity greater than or equal to 90%. Specificity: The ability of the TruScore device to correctly identify lesions that are not cancerous (true negatives). For non-pigmented lesions, the specificity goal is 60% at the lower bound of the two-sided 95% confidence interval. For pigmented lesions, the specificity goal is 15% at the lower bound of the two-sided 95% confidence interval.
Time frame: At the subject's TruScore measurement of their skin lesion right before the skin lesion is biopsied. There is no other time frame that the subject is involved in the study.
Adverse Device Events
The study will track and report the number of adverse device events that occur during the use of the TruScore device. This includes any negative reactions or side effects experienced by patients when the device is used on their skin lesions.
Time frame: At the subject's TruScore measurement of their skin lesion right before the skin lesion is biopsied. There is no other time frame that the subject is involved in the study.
Sensitivity and Specificity for Subgroups
The study will estimate the sensitivity and specificity of the TruScore device for different subgroups based on patient profiles (e.g., age, gender, skin type) and lesion characteristics (e.g., location, type of lesion). This analysis aims to ensure that the device performs consistently across various patient demographics and lesion types.
Time frame: At the subject's TruScore measurement of their skin lesion right before the skin lesion is biopsied. There is no other time frame that the subject is involved in the study.
Plan to share: Undecided — In this pre-market study aimed at obtaining FDA 510(k) clearance, Individual Participant Data (IPD) will not be shared to protect the privacy and confidentiality of the participants. Ensuring the security of participants' personal information is crucial, especially in clinical trials, to maintain trust and comply with ethical standards and regulatory requirements. By not sharing IPD, the study adheres to privacy laws and guidelines, safeguarding participants' sensitive information while focusing on evaluating the TruScore device's performance.
No publications or documents are linked to this record.
Started Sep 2025 (actual). Primary completion is estimated for May 2027, 20 months after the start.
Of 227 interventional studies with no phase under Melanoma, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 62. This study's planned 20 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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