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 Overview

• Status: Completed
• Conditions: Malignant Melanoma
• Intervention / Treatment: Device: SciBase III Electrical Impedance Spectrometer

• Study Type: Interventional
• Enrollment (Actual): 1951
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, 41345
    • Sahlgrenska University Hospital
• United States
  • Arizona
    • Tucson, Arizona, United States, 85719
      • University of Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: QUADRUPLE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

OTHER: 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.

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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: SciBase AB
• Investigators: Study Director: Ulrik H Birgersson, PhD, SciBase and Karolinska Institutet

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (ACTUAL): September 1, 2011
• Study Completion (ACTUAL): October 1, 2011

Study Registration Dates

• First Submitted: February 25, 2010
• First Submitted That Met QC Criteria: February 25, 2010
• First Posted (ESTIMATE): February 26, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): December 30, 2013
• Last Update Submitted That Met QC Criteria: November 8, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: SIMPS