SciBase International Melanoma Pivotal Study

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.

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.