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
Results First Received: June 12, 2013  
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
Condition: Malignant Melanoma
Intervention: Device: SciBase III Electrical Impedance Spectrometer

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

Recruitment was conducted at five (5) US investigational sites and at seventeen (17) European investigational sites.

Recruitment period 2010-2011. In 2012 the last histological analysis was performed.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Potential study subjects were screened according to the inclusion/exclusion criteria. All study eligible skin lesion(s) were then examined with the investigational device, photographed and removed by an excisional biopsy.

Reporting Groups
  Description
Only One Arm in the Study, Thus Not Applicable. No text entered.

Participant Flow:   Overall Study
    Only One Arm in the Study, Thus Not Applicable.  
STARTED     1951  
COMPLETED     1942  
NOT COMPLETED     9  
Subjects signed ICF could not be located                 1  
Screen failure                 8  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All study eligible skin lesion(s) were examined with the investigational device, photographed and removed by an excisional biopsy.

Reporting Groups
  Description
Biopsied Skin Lesions Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto

Baseline Measures
    Biopsied Skin Lesions  
Number of Participants  
[units: participants]
  1942  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     1499  
>=65 years     443  
Age  
[units: years]
Mean ± Standard Deviation
  49.8  ± 16.9  
Gender  
[units: participants]
 
Female     1013  
Male     929  
Region of Enrollment  
[units: participants]
 
United States     458  
Europe     1484  



  Outcome Measures

1.  Primary:   SciBase Sensitivity and Specificity   [ Time Frame: Post data lock ]

2.  Secondary:   Sensitivity and Specificity   [ Time Frame: Post data lock ]
Results not yet posted.   Anticipated Posting Date:   08/2013   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Director of Clinical Operations
Organization: SciBase
phone: +46841062001
e-mail: per.svedenhag@scibase.se


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