CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,951 enrolled
Drug / intervention
SciBase III Electrical Impedance Spectrometerdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01077050
NCT01077050N/ACompleted
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SciBase International Melanoma Pivotal Study

SciBase AB·interventional·Posted Feb 26, 2010·Updated Dec 30, 2013

In Brief

A clinical study evaluating SciBase III Electrical Impedance Spectrometer for Malignant Melanoma. Completed, enrolled 1,951 participants across 2 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalignant Melanoma
CountriesSweden, United States
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 26, 2010
Enrollment StartApr 1, 2010
Primary CompletionSep 1, 2011
Study CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 16.3 years ago

Interventions

SciBase III Electrical Impedance Spectrometerdevice

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.