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SciBase International Melanoma Pivotal Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01077050
Recruitment Status : Completed
First Posted : February 26, 2010
Results First Posted : December 30, 2013
Last Update Posted : December 30, 2013
Sponsor:
Information provided by (Responsible Party):
SciBase AB

Tracking Information
First Submitted Date  ICMJE February 25, 2010
First Posted Date  ICMJE February 26, 2010
Results First Submitted Date  ICMJE June 12, 2013
Results First Posted Date  ICMJE December 30, 2013
Last Update Posted Date December 30, 2013
Study Start Date  ICMJE April 2010
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 25, 2010)
Device Sensitivity and Specificity [ Time Frame: One year ]
Consists of two co-endpoints aiming to show a Sensitivity (device) ≥ 0.90 to detect malignant melanoma and a Sensitivity - (1-Specificity) > 0.00
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2013)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2010)
Incidence of adverse events [ Time Frame: One year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SciBase International Melanoma Pivotal Study
Official Title  ICMJE SciBase International Melanoma Pivotal Study
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE Malignant Melanoma
Intervention  ICMJE 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.
Study Arms  ICMJE 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 8, 2013)
1951
Original Estimated Enrollment  ICMJE
 (submitted: February 25, 2010)
1100
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01077050
Other Study ID Numbers  ICMJE SIMPS
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party SciBase AB
Study Sponsor  ICMJE SciBase AB
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ulrik H Birgersson, PhD SciBase and Karolinska Institutet
PRS Account SciBase AB
Verification Date November 2013

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