SciBase International Melanoma Pivotal Study

Summary

The purpose of this clinical investigation was to determine the safety and effectiveness of the SciBase III device (Test) designed to help distinguish between malignant melanoma and benign lesions, using electrical impedance spectroscopy (EIS) relative to the histological gold standard (Reference).

The purpose of the study is to collect data to support a Pre-market Application(PMA) to obtain Food and Drug Administration(FDA) approval to market the SciBase III Electrical Impedance Spectrometer.

Conditions

• Malignant Melanoma

Interventions

DEVICE

SciBase III Electrical Impedance Spectrometer

SciBase III Electrical Impedance Spectrometer is based on Electrical Impedance Spectroscopy (EIS). EIS is a measure of the overall resistance within a skin tissue, at alternating currents of various frequencies. Enrolled subject will undergo skin measurements with SciBase III Electrical Impedance Spectrometer. The relevant skin lesion(s) will be excised and diagnosed as per routine treatment.

Sponsors & Collaborators

• SciBase AB

  lead OTHER

Principal Investigators

• Ulrik H Birgersson, PhD · SciBase and Karolinska Institutet

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

QUADRUPLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-04-30

Primary Completion

2011-09-30

Completion

2011-10-31

Countries

• United States
• Sweden

Study Locations