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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Malignant Melanoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University Hospital, Gothenburg, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SciBase III Electrical Impedance Spectrometer

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.

Primary outcomes

SciBase Sensitivity and Specificity

Time frame: Post data lock
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.

Secondary outcomes

Sensitivity and Specificity

Time frame: Post data lock

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.

Sponsors and collaborators

Lead sponsor

SciBase AB

Other

Registry information

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Feb 26, 2010
Registry last updated: Dec 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed