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Completed

NCT Number: NCT04705168

Study of the Nevisense Device to Assess Atypical Skin Lesions

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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Key information

Conditions

Nevus Large Acquired Nevi Multiple Nevi Neoplasms Neoplasms by Histologic Type Nevi and Melanomas Skin Lesion

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Basking Ridge (Consent only), Basking Ridge, New Jersey, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Nevisense electrical impedance spectroscopy

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

Primary outcomes

  1. Electrical impedance spectroscopy scores of participants' nevi

    Time frame: 2 weeks

    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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jan 12, 2021
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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