Clinical Trial: Evaluation of Pigmented Skin Lesions With MelaFind(R) System

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Evaluation of Pigmented Skin Lesions With MelaFind(R) System

Brief Summary: The purpose of this clinical trial is to demonstrate that MelaFind®, a new instrument that uses machine vision for non-invasive early detection of cutaneous pigmented malignant melanoma, is safe and effective. MelaFind® acquires digital images of the lesion with illumination in different spectral bands, from visible to near infrared, and automatically analyzes these images. Diagnostic accuracy of MelaFind® and that of study dermatologists will be evaluated. The reference standard will be final interpretation of lesions by central dermatohistopathology.

Detailed Summary:
Sponsor: MELA Sciences, Inc.

Current Primary Outcome: Sensitivity and Specificity [ Time Frame: Within 120 days of Data Lock ]

Sensitivity is the fraction of correctly identified cases of melanoma. Specificity is the fraction of correctly identified cases of non-melanoma.


Original Primary Outcome:

  • Sensitivity
  • Specificity


Current Secondary Outcome:

  • Biopsy Ratio [ Time Frame: Within 120 days of Data Lock ]
    Number of lesions bioopsied to melanomas detected
  • Exploratory Analyses [ Time Frame: Within 365 days of Data Lock ]


Original Secondary Outcome:

  • Diagnostic Accuracy
  • ROC Curve Analysis
  • Exploratory Analyses


Information By: MELA Sciences, Inc.

Dates:
Date Received: February 8, 2007
Date Started: January 2007
Date Completion:
Last Updated: February 10, 2012
Last Verified: February 2012