SciBase International Melanoma Pivotal Study

Malignant Melanoma Clinical Trial

Official title:

SciBase International Melanoma Pivotal Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01077050
• Other study ID #: SIMPS
• Status: Completed
• Phase: N/A
• First received: February 25, 2010
• Last updated: November 8, 2013
• Start date: April 2010
• Est. completion date: October 2011

Study information

• Verified date: November 2013
• Source: SciBase AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1951
• Est. completion date: October 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Malignant Melanoma
• Melanoma

Intervention

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.

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg
United States	University of Arizona	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
SciBase AB

Countries where clinical trial is conducted

United States,  Sweden, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes