This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

SciBase International Melanoma Pivotal Study

This study has been completed.
Information provided by (Responsible Party):
SciBase AB Identifier:
First received: February 25, 2010
Last updated: November 8, 2013
Last verified: November 2013

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.

Condition Intervention
Malignant Melanoma Device: SciBase III Electrical Impedance Spectrometer

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: SciBase International Melanoma Pivotal Study

Resource links provided by NLM:

Further study details as provided by SciBase AB:

Primary Outcome Measures:
  • SciBase Sensitivity and Specificity [ Time Frame: Post data lock ]

    This study has two co-primary objectives, aiming to demonstrate the accuracy of SciBase device:

    1. Sensitivity ≥ 0.90 to detect Melanoma
    2. 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 Outcome Measures:
  • 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.

Enrollment: 1951
Study Start Date: April 2010
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01077050

United States, Arizona
University of Arizona
Tucson, Arizona, United States, 85719
Sahlgrenska University Hospital
Gothenburg, Sweden, 41345
Sponsors and Collaborators
SciBase AB
Study Director: Ulrik H Birgersson, PhD SciBase and Karolinska Institutet
  More Information

Responsible Party: SciBase AB Identifier: NCT01077050     History of Changes
Other Study ID Numbers: SIMPS
Study First Received: February 25, 2010
Results First Received: June 12, 2013
Last Updated: November 8, 2013

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas processed this record on September 21, 2017