Evaluation of Pigmented Skin Lesions With MelaFind(R) System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MELA Sciences, Inc.
ClinicalTrials.gov Identifier:
NCT00434057
First received: February 8, 2007
Last updated: February 10, 2012
Last verified: February 2012
Results First Received: May 26, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Melanoma
Intervention: Device: MelaFind(R)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Biopsied Pigmented Skin Lesions Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto

Participant Flow:   Overall Study
    Biopsied Pigmented Skin Lesions  
STARTED     1383  
COMPLETED     1382 [1]
NOT COMPLETED     1  
Withdrawal by Subject                 1  
[1] One patient withdrew from the study after signing the Informed Consent Form



  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.
No text entered.

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

Baseline Measures
    Biopsied Pigmented Skin Lesions  
Number of Participants  
[units: participants]
  1383  
Age  
[units: participants]
 
<=18 years     56  
Between 18 and 65 years     1056  
>=65 years     271  
Age  
[units: years]
Mean ± Standard Deviation
  48  ± 18.3  
Gender  
[units: participants]
 
Female     745  
Male     638  
Region of Enrollment  
[units: participants]
 
United States     1383  



  Outcome Measures

1.  Primary:   Sensitivity and Specificity   [ Time Frame: Within 120 days of Data Lock ]

2.  Secondary:   Biopsy Ratio   [ Time Frame: Within 120 days of Data Lock ]
Results not yet posted.   Anticipated Posting Date:   12/2009   Safety Issue:   No

3.  Secondary:   Exploratory Analyses   [ Time Frame: Within 365 days of Data Lock ]
Results not yet posted.   Anticipated Posting Date:   02/2010   Safety Issue:   No


  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
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  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 less than or equal to 60 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: Joanna Adrian / Director, Clinical Operations and Medical Affairs
Organization: Electro-Optical Sciences, Inc.
phone: (914)591-3783 ext 732
e-mail: adrian@eosciences.com


No publications provided by MELA Sciences, Inc.

Publications automatically indexed to this study:

Responsible Party: MELA Sciences, Inc.
ClinicalTrials.gov Identifier: NCT00434057     History of Changes
Other Study ID Numbers: 20061
Study First Received: February 8, 2007
Results First Received: May 26, 2009
Last Updated: February 10, 2012
Health Authority: United States: Food and Drug Administration