SciBase International Melanoma Pivotal Study

SciBase

Status: Completed

Conditions: Malignant Melanoma

Treatments: Device: SciBase III Electrical Impedance Spectrometer

Study type: Interventional

Funder types: Other

Identifiers

NCT01077050

SIMPS

Details and patient eligibility

About

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.

Enrollment: 1,951 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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1,951 participants in 1 patient group

SciBase III

Other group

Description:

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.

Treatment:

Device: SciBase III Electrical Impedance Spectrometer