CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,383 enrolled
Drug / intervention
MelaFind(R)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00434057
NCT00434057Phase 3Completed

Evaluation of Pigmented Skin Lesions With MelaFind(R) System

MELA Sciences, Inc.·interventional·Posted Feb 12, 2007·Updated Feb 14, 2012

In Brief

A Phase 3 clinical trial evaluating MelaFind(R) for Melanoma. Completed, enrolled 1,383 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 12, 2007
Enrollment StartJan 1, 2007
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 19.4 years ago

Interventions

MelaFind(R)device

Biopsy ratio comparison