SciBase International Melanoma Pivotal Study

NCT ID: NCT01077050

Last Updated: 2013-12-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1951 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2011-10-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: QUADRUPLE

Study Groups

SciBase III

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.

Group Type: OTHER

SciBase III Electrical Impedance Spectrometer

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

SciBase AB

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ulrik H Birgersson, PhD

Role: STUDY_DIRECTOR

SciBase and Karolinska Institutet

Locations

University of Arizona

Tucson, Arizona, United States

Sahlgrenska University Hospital

Gothenburg, , Sweden

Countries

United States; Sweden

References

Aberg P, Nicander I, Holmgren U, Geladi P, Ollmar S. Assessment of skin lesions and skin cancer using simple electrical impedance indices. Skin Res Technol. 2003 Aug;9(3):257-61. doi: 10.1034/j.1600-0846.2003.00017.x.

Reference Type: BACKGROUND

PMID: 12877688 (View on PubMed)

Aberg P, Nicander I, Hansson J, Geladi P, Holmgren U, Ollmar S. Skin cancer identification using multifrequency electrical impedance--a potential screening tool. IEEE Trans Biomed Eng. 2004 Dec;51(12):2097-102. doi: 10.1109/TBME.2004.836523.

Reference Type: BACKGROUND

PMID: 15605856 (View on PubMed)

Other Identifiers

SIMPS

Identifier Type: -

Identifier Source: org_study_id