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Study of the Nevisense Device to Assess Atypical Skin Lesions

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04705168
Enrollment
40
Registered
2021-01-12
Start date
2021-01-08
Completion date
2025-11-18
Last updated
2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Large Acquired Nevi, Multiple Nevi, Nevus, Skin Lesion

Keywords

Atypical Skin Lesions, Skin Lesions, Multiple Nevi, Large Acquired Nevi, Memorial Sloan Kettering Cancer Center, 20-010

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.

Interventions

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

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Electrical impedance spectroscopy scores of participants' nevi2 weeksThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026