Clinical trial NCT01077050: SciBase International Melanoma Pivotal Study
Official title: SciBase International Melanoma Pivotal Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Melanoma
Lead sponsor: SciBase AB
Sponsor class: OTHER
First posted: 2010-02-26
Enrollment: 1951
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: SciBase Sensitivity and Specificity
timeFrame: Post data lock
Secondary outcomes:
measure: Sensitivity and Specificity
timeFrame: Post data lock
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: SciBase and Karolinska Institutet
name: Ulrik H Birgersson, PhD
role: STUDY_DIRECTOR
References:
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. doi: 10.1034/j.1600-0846.2003.00017.x.
citation: 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.