Melanoma and Other Malignant Neoplasms of SkinStandaloneNCT06793423
TruScore Standalone Clinical Study
A study testing Skin lesion diagnostic device evaluation in people with Melanoma and Other Malignant Neoplasms of Skin and Basal Cell Carcinoma of Skin, run by VeriSkin, Inc. at 6 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Melanoma and Other Malignant Neoplasms of Skin, Basal Cell Carcinoma of Skin, Squamous Cell Carcinoma of the Skin
- What is being tested?
- Skin lesion diagnostic device evaluation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 464 participants
- Where
- 6 sitesUnited States
- Study dates
- 25 Sep 2025to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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: Participants must be willing and able to read, comprehend, and sign the study-specific informed consent form.
Who cannot join
- Non-measurable Skin Surface: Lesions on skin surfaces that cannot be measured (e.g., lesions on a stalk).
- Inaccessible Skin Surface: Lesions on skin surfaces that are not accessible (e.g., inside ears, under nails).
- Specific Body Parts: Lesions located on the nose, lips, ears, or eyelids.
- Acral Skin: Lesions located on acral skin (e.g., soles of the feet, palms of the hands).
- Skin Conditions: Lesions located on areas with scars, crusts, psoriasis, eczema, dermatitis, or similar skin conditions that could influence blood flow where the lesion is located.
- Hair-covered Areas: Lesions on hair-covered areas (e.g., scalp, beards, mustaches) unless the lesion is not covered by hair.
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- Genitalia: Lesions located on the genitalia.
- Previously Biopsied or Traumatized Areas: Lesions located in areas that have been previously biopsied, subjected to any kind of surgical intervention, or traumatized.
- Mucosal Surfaces: Lesions located on mucosal surfaces.
- Non-intact Skin: Skin in the measurement area that is not intact (e.g., bleeding or with clinically noticeable ulceration).
- Foreign Matter: Lesions with foreign matter present (e.g., tattoos, splinters).
- Acute Sunburn: Lesions located on areas with acute sunburn.
- Collision Lesions: Lesions that are collision lesions (i.e., lesions that overlap or are adjacent to each other).
- Light Sensitivities: Patients with porphyria or other light sensitivities, such as phototoxicity or photoallergic reactions from antibiotics.
- Dermatologist-selected Lesions: Lesions that have been selected by a dermatologist.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites
VA Boston Healthcare System
Boston, Massachusetts, 02130-001
John Hopkins Health Care & Surgery Center - Green Spring Station, Lutherville
Lutherville, Maryland, 21093
Penn Dermatology
Philadelphia, Pennsylvania, 19104
Golden State Dermatology
Pleasanton, California, 94588
James A Haley Veterans Hospital
Tampa, Florida, 33612
Golden State Dermatology
Walnut Creek, California, 94598
About this study
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
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Melanoma and Other Malignant Neoplasms of Skin, Basal Cell Carcinoma of Skin, Squamous Cell Carcinoma of the Skin
- Being tested
- Skin lesion diagnostic device evaluation
- Keywords
- TurScore device, Skin cancer diagnosis, Melanoma detection, Basal cell carcinoma, Non-invasive diagnostic tool, AI algorithm, Hemodynamic analysis, Vascular abnormalitites, Dermatopathology, Pigmented lesions, Non-pigmented lesions, Early detection of skin cancer, Referral to dermatologist
- Medical subject headings
- Melanoma, Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin lesion diagnostic device evaluationDevice
TruScore Device Evaluation for Skin Cancer Diagnosis
| Study group | Role | What they receive |
|---|---|---|
| Pigmented Skin Lesions | Experimental | Different AI algorithm used for pigmented skin lesions and is selected before doing the skin measurement. Receives: Device: Skin lesion diagnostic device evaluation |
| Non pigmented skin lesions | Experimental | Different AI algorithm used for non-pigmented skin lesions and is selected before doing the skin measurement. Receives: Device: Skin lesion diagnostic device evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Secondary outcomes (2)
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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start25 Sep 2025
- Primary completion30 May 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma and Other Malignant Neoplasms of SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- "platform model" refers to the study design that allows for the separate evaluation of different types of skin lesions-specifically, pigmented and non-pigmented lesions. This approach is known as a Platform Trial Design. A platform trial design is a type of clinical trial that enables the simultaneous evaluation of multiple interventions or subgroups within a single overarching trial structure. In this study, the platform model facilitates the separate evaluation of pigmented (e.g., melanoma) and non-pigmented (e.g., basal cell carcinoma and squamous cell carcinoma) skin lesions. Here's how it works: Separate Algorithms and Cutoff Values: The TruScore device uses distinct algorithms and corresponding cutoff values tailored to pigmented and non-pigmented lesions. This ensures that the sensitivity and specificity of the device are appropriately calibrated for each type of lesion.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 464 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VeriSkin, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lead Study Principal Investigator, Principal investigator, Golden State Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793423
- Sponsor's protocol ID
- 25-001-PRO
- Other IDs
- 2R44CA203038
- Acronym
- Standalone
- Status last verified
- Oct 2026
- First submitted
- 12 Jan 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06793423
- Acronym / sponsor ID
- Standalone / 25-001-PRO
- Conditions
- Melanoma and Other Malignant Neoplasms of Skin, Basal Cell Carcinoma of Skin, Squamous Cell Carcinoma of the Skin
- Keywords
- TurScore device, Skin cancer diagnosis, Melanoma detection, Basal cell carcinoma, Non-invasive diagnostic tool, AI algorithm, Hemodynamic analysis, Vascular abnormalitites
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 464 participants (estimated)
- Lead sponsor
- VeriSkin, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 25 Sep 2025 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- "platform model" refers to the study design that allows for the separate evaluation of different types of skin lesions-specifically, pigmented and non-pigmented lesions. This approach is known as a Platform Trial Design. A platform trial design is a type of clinical trial that enables the simultaneous evaluation of multiple interventions or subgroups within a single overarching trial structure. In this study, the platform model facilitates the separate evaluation of pigmented (e.g., melanoma) and non-pigmented (e.g., basal cell carcinoma and squamous cell carcinoma) skin lesions. Here's how it works: Separate Algorithms and Cutoff Values: The TruScore device uses distinct algorithms and corresponding cutoff values tailored to pigmented and non-pigmented lesions. This ensures that the sensitivity and specificity of the device are appropriately calibrated for each type of lesion.
| Arm | Type | Receives |
|---|---|---|
| Pigmented Skin Lesions | Experimental | Device: Skin lesion diagnostic device evaluationDifferent AI algorithm used for pigmented skin lesions and is selected before doing the skin measurement. |
| Non pigmented skin lesions | Experimental | Device: Skin lesion diagnostic device evaluationDifferent AI algorithm used for non-pigmented skin lesions and is selected before doing the skin measurement. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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: Participants must be willing and able to read, comprehend, and sign the study-specific informed consent form.
Key exclusion criteria (15 listed)
- Non-measurable Skin Surface: Lesions on skin surfaces that cannot be measured (e.g., lesions on a stalk).
- Inaccessible Skin Surface: Lesions on skin surfaces that are not accessible (e.g., inside ears, under nails).
- Specific Body Parts: Lesions located on the nose, lips, ears, or eyelids.
- Acral Skin: Lesions located on acral skin (e.g., soles of the feet, palms of the hands).
- Skin Conditions: Lesions located on areas with scars, crusts, psoriasis, eczema, dermatitis, or similar skin conditions that could influence blood flow where the lesion is located.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin lesion diagnostic device evaluationTruScore Device Evaluation for Skin Cancer Diagnosis | Device | Non pigmented skin lesions, Pigmented Skin Lesions |
Primary outcome
Accuracy of the TruScore device in diagnosing suspicious 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.
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.
2 secondary outcomes
Adverse Device Events
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lead Study Principal Investigator principal investigator
Golden State Dermatology
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin lesion diagnostic device evaluation in people with Melanoma and Other Malignant Neoplasms of Skin and Basal Cell Carcinoma of Skin, run by VeriSkin, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of the TruScore device in diagnosing suspicious 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.