Study of the Nevisense Device to Assess Atypical Skin Lesions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-08

Study Completion Date

2025-11-18

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.

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Detailed Description

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Conditions

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Nevus Multiple Nevi Large Acquired Nevi Skin Lesion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants displaying nevi

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.

Nevisense electrical impedance spectroscopy

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Nevisense electrical impedance spectroscopy

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

Intervention Type DIAGNOSTIC_TEST

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).

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No