NCT01077050

SciBase International Melanoma Pivotal Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,951 (actual)
• Sponsor: SciBase AB · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2010-04-01
• Primary completion: 2011-09-01
• Completion: 2011-10-01
• First posted: 2010-02-26
• Last updated: 2013-12-30
• Results posted: 2013-12-30

Locations

2 sites across 2 countries: United States, Sweden