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Evaluation of Pigmented Skin Lesions With MelaFind(R) System

NCT00434057 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1383

Last updated 2012-02-14

Study results available
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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.

Conditions

Interventions

DEVICE

MelaFind(R)

Biopsy ratio comparison

Sponsors & Collaborators

  • MELA Sciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Dina Gutkowicz-Krusin, PhD · Electro-Optical Sciences, Inc.

  • Joseph V Gulfo, MD, MBA · Electro-Optical Sciences, Inc.

  • Harold S Rabinovitz, MD · Skin and Cancer Associates

  • Armand B Cognetta, Jr, MD · Dermatology Associates of Tallahassee

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00434057 on ClinicalTrials.gov