Study of the Nevisense Device to Assess Atypical Skin Lesions

Completed

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

In brief

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.

Key facts

Study ID

NCT04705168

Run by

Memorial Sloan Kettering Cancer Center

People needed

40

Starts

2021-01-08

Expected to finish

2025-11-18

Last updated by the study team

2025-11-20

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• Memorial Sloan Kettering Basking Ridge (Consent only) — Basking Ridge, New Jersey, United States
• Memorial Sloan Kettering Westchester (Consent only) — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States

Full record on ClinicalTrials.gov

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