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 ]
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