Study of the Nevisense Device to Assess Atypical Skin Lesions

Study Overview
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Brief Summary
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The purpose of this study is to find out whether the Nevisense device can provide useful information about atypical moles to complement the usual assessments done during routine screening for melanoma. Assessing particpants' moles with the Nevisense device may help improve screening methods for the early detection of melanoma in people with atypical mole syndrome.

Official Title
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Performance of Nevisense Electrical Impedance Spectroscopy in Patients With Multiple Nevi and Large Acquired Nevi (LAN)

Conditions
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Nevus, Multiple Nevi, Large Acquired Nevi, Skin Lesion

Intervention / Treatment
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* Diagnostic Test: Nevisense electrical impedance spectroscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (> 30 years of age) at the time of the initial study visit. Patients displaying a phenotype that consists of ≥ 100 nevi on the entire cutaneous surface and at least three large acquired nevi (LAN) > 5 mm in diameter. These patients have atypical mole syndrome, which is a high-risk nevus phenotype and the target patient population in this study. Patients with at least three clinically stable nevi between 5 and 20 mm in diameter. Patients (or LAR) who are able to provide informed consent. Patients with previous total body photography images taken at least 3 years prior Exclusion Criteria: Patients without at least three clinically stable nevi between 5 and 20 mm in diameter. Patients with any electronic implantable devices. Patients who are pregnant (verbally confirmed with the participant).

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants displaying nevi<br>Participants displaying a phenotype that consists of ≥ 100 nevi on the entire cutaneous surface and at least three large acquired nevi (LAN) > 5 mm in diameter. These patients have atypical mole syndrome, which is a high-risk nevus phenotype and the target patient population in this study. | Diagnostic Test: Nevisense electrical impedance spectroscopy<br>* Each participants will undergo Nevisense electrical impedance spectroscopy in order to characterize the electrical impedance spectroscopy scores of nevi in patients with ≥ 100 nevi on the entire cutaneous surface and at least three large acquired nevi (LAN) > 5 mm in diameter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrical impedance spectroscopy scores of participants' nevi | The primary objective is to characterize the electrical impedance spectroscopy scores of nevi in patients with ≥ 100 nevi on the entire cutaneous surface and at least three large acquired nevi (LAN) > 5 mm in diameter. | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atypical Skin Lesions, Skin Lesions, Multiple Nevi, Large Acquired Nevi, Memorial Sloan Kettering Cancer Center, 20-010