SciBase International Melanoma Pivotal Study
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 Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
|Official Title:||SciBase International Melanoma Pivotal Study|
- SciBase Sensitivity and Specificity [ Time Frame: Post data lock ] [ Designated as safety issue: Yes ]
This study has two co-primary objectives, aiming to demonstrate the accuracy of SciBase device:
- Sensitivity ≥ 0.90 to detect Melanoma
- Sensitivity - (1-Specificity) > 0.00
Sensitivity is the proportion of correctly identified cases of Melanoma. Specificity is the proportion of correctly identified cases of non-melanoma.
- Sensitivity and Specificity [ Time Frame: Post data lock ] [ Designated as safety issue: Yes ]
Secondary confirmatory objective included two co-secondary endpoints that were defined similarly to the co-primary endpoints, but used the Secondary definition of dichotomous reference diagnosis.
Positive Reference Diagnosis: Melanoma, Squamous Cell Carcinoma, Basal Cell Carcinoma, Severe Dysplastic Nevus (High grade dysplasia)
Negative Reference Diagnosis: All other skin lesions.
|Study Start Date:||April 2010|
|Study Completion Date:||October 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Subjects with suspected malignant melanoma or lesions designated for total excision were included into the study. To ensure no selection bias, all eligible lesions from a subject were included into the study. All study eligible skin lesion(s) were examined with the investigational device, photographed and removed by an excisional biopsy.
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.
|United States, Arizona|
|University of Arizona|
|Tucson, Arizona, United States, 85719|
|Sahlgrenska University Hospital|
|Gothenburg, Sweden, 41345|
|Study Director:||Ulrik H Birgersson, PhD||SciBase and Karolinska Institutet|