UPCC 07625 Non-Significant Risk (NSR) Device Study to Evaluate Device Performance on Pigmented, Non-/Pigmented Skin Lesions and Histological Diagnoses: TruScore Standalone Clinical Study

Study on Device for Assessing Skin Lesions

Enrolling By Invitation
99 years or below
All
Phase N/A
1 Location

Brief description of study

This is a non-randomized, multi-center, blinded, non-significant risk (NSR) clinical study evaluating the accuracy of the TruScore device in assessing skin lesions suggestive of melanoma, basal cell carcinoma, and squamous cell carcinoma in patients 22 years. Lesions assessed as suspicious by non-dermatologists will undergo TruScore analysis and biopsy. Study outcomes include sensitivity, specificity, and safety across lesion subtypes.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Medical Research
  • Age: 99 years or below
  • Gender: All

TBD

This study investigates the use of a device to evaluate skin lesions that may suggest conditions like melanoma, basal cell carcinoma, and squamous cell carcinoma. The purpose of this study is to assess how accurately the device can identify these conditions in patients 22 years and older.

Participants will have their skin lesions examined using the device, followed by a biopsy to confirm the diagnosis. The study will measure the device's sensitivity and specificity in identifying different types of skin lesions.

  • Who can participate: Participants must be 22 years or older with skin lesions suggestive of melanoma, basal cell carcinoma, or squamous cell carcinoma.
  • Study details: Participants will have their lesions assessed using the investigational device, and a biopsy will be performed to confirm the diagnosis.
Updated on 22 Apr 2026. Study ID: 25-1335
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Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.

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