SciBase International Melanoma Pivotal Study

Study Overview
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Brief Summary
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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.

Official Title
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SciBase International Melanoma Pivotal Study

Conditions
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Malignant Melanoma

Intervention / Treatment
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* Device: SciBase III Electrical Impedance Spectrometer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria For inclusion in the study, all subjects had to fulfill all of the following criteria: Men or women of any ethnic group aged ≥18 years Primary lesions (i.e., not metastases or recurrent lesions) that the physicians choose to excise. Lesion ≥ 2 mm in diameter and ≤ 20 mm in diameter In subjects with multiple skin lesions, all lesions destined for excision must be identified for purposes of study participation. Note: a subject may only be entered into the study once. The subject is willing and able to read, understand and sign the study specific informed consent form. Exclusion Criteria: Subjects were excluded from the study if they fulfilled any of the following criteria: Skin surface not measurable, e.g. lesion on a stalk Skin surface not accessible, e.g. inside ears, under nails Lesion located on acral skin, e.g. sole or palms. Lesion located on areas of scars, crusts, psoriasis, eczema or similar skin conditions. Lesion on hair-covered areas, e.g. scalp, beards, moustaches or whiskers. Lesion located on genitalia. Lesion located in an area that has been previously biopsied or subjected to any kind of surgical intervention or traumatized. Lesion located on mucosal surfaces. Skin is not intact (measurement area) e.g. bleeding or with clinical noticeable ulceration. Lesion with foreign matter, e.g. tattoo, splinter Lesion and/or reference located on acute sunburn.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: SciBase III<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SciBase Sensitivity and Specificity | 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. | Post data lock | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and Specificity | 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. | Post data lock |