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NCT04705168 Clinical Trial

Study of the Nevisense Device to Assess Atypical Skin Lesions

Skin Lesion Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04705168
Other study ID # 21-010
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 8, 2021
Est. completion date January 8, 2025

Study information
Verified date February 2024
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 40
Est. completion date January 8, 2025
Est. primary completion date January 8, 2025
Accepts healthy volunteers No
Gender All
Age group 30 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• 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

Locations
Country Name City State
United States 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

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Electrical impedance spectroscopy scores of participants' nevi 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. 2 weeks
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