Post-Approval Study of MelaFind

Status Terminated

Clinical Trial Summary

The purpose of this study is to collect data to describe the real-world use and safety and effectiveness of MelaFind® in a post-approval clinical setting.

Clinical Trial Description

The primary objective of this study to test the hypothesis that, among eligible and evaluable lesions with central histological reference standard status melanoma or high-grade lesion, the relative sensitivity ρ comparing enrolling dermatologists after MelaFind use with enrolling dermatologists if MelaFind were not available is greater than 110%. This represents a clinically meaningful increase in sensitivity.

The secondary objectives of this study are to evaluate real-world use and safety and effectiveness of MelaFind in a clinical setting. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Melanoma

Clinical Trial Details

NCT number	NCT01700114
Study type	Observational
Source	MELA Sciences, Inc.
Contact
Status	Terminated
Phase	N/A
Start date	November 2012
Completion date	January 2016

View Details

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