Study of the Nevisense Device to Assess Atypical Skin Lesions

Active, not recruiting

• Conditions: Nevus; Skin Lesion; Multiple Nevi; Large Acquired Nevi
• Interventions: Diagnostic Test: Nevisense electrical impedance spectroscopy

• Registration Number: NCT04705168
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-08
• Study First Submitted: 2021-01-08
• Study First Submitted QC: 2021-01-08
• Study First Posted: 2021-01-12
• Status Verified: 2025-02
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18
• Primary Completion: 2026-01-08
• Study Completion: 2026-01-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants displaying nevi	Nevisense electrical impedance spectroscopy	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.

Primary Outcome Measures

Name	Time	Method
Electrical impedance spectroscopy scores of participants' nevi	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.

Trial Locations

Locations (3)

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