SciBase International Melanoma Pivotal Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
SciBase AB
ClinicalTrials.gov Identifier:
NCT01077050
First received: February 25, 2010
Last updated: November 8, 2013
Last verified: November 2013
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  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 ClinicalTrials.gov identifier: NCT01077050

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

Publications:
Responsible Party: SciBase AB
ClinicalTrials.gov 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
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on October 21, 2014