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

February 25, 2010
November 8, 2013
April 2010
September 2011   (final data collection date for primary outcome measure)
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.

Device Sensitivity and Specificity [ Time Frame: One year ] [ Designated as safety issue: No ]
Consists of two co-endpoints aiming to show a Sensitivity (device) ≥ 0.90 to detect malignant melanoma and a Sensitivity - (1-Specificity) > 0.00
Complete list of historical versions of study NCT01077050 on ClinicalTrials.gov Archive Site
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.

Incidence of adverse events [ Time Frame: One year ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
SciBase International Melanoma Pivotal Study
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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Malignant Melanoma
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.
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.
Intervention: Device: SciBase III Electrical Impedance Spectrometer

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1951
October 2011
September 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Sweden
 
NCT01077050
SIMPS
Not Provided
SciBase AB
SciBase AB
Not Provided
Study Director: Ulrik H Birgersson, PhD SciBase and Karolinska Institutet
SciBase AB
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP