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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01077050
Other study ID # SIMPS
Secondary ID
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


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
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