Evaluation of Pigmented Skin Lesions With MelaFind(R) System

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1383 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Melanoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Biopsied Pigmented Skin Lesions

Pigmented skin lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto

Group Type OTHER

MelaFind(R)

Intervention Type DEVICE

Biopsy ratio comparison

Interventions

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MelaFind(R)

Biopsy ratio comparison

Intervention Type DEVICE

Other Intervention Names

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MF100 MelaFind Device System MelaFind Device

Eligibility Criteria

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Inclusion Criteria

* The lesion is pigmented (i.e., melanin, keratin, blood)
* Clinical management of the lesion by the examining dermatologist is either biopsy of the lesion in toto, or 3-month follow-up of the lesion
* The diameter of the pigmented area is between 2 and 22 millimeters
* The lesion is accessible to the MelaFind hand-held imaging device
* The patient, or a legally authorized representative, has consented to participate in the study and has signed the Informed Consent Form

Exclusion Criteria

* The patient has a known allergy to isopropyl alcohol
* The lesion has been previously biopsied, excised, or traumatized
* The skin is not intact (e.g., open sores, ulcers, bleeding)
* The lesion is within 1 cm of the eye
* The lesion is on mucosal surfaces (e.g., lips, genitals)
* The lesion is on palmar hands
* The lesion is on plantar feet
* The lesion is on or under nails
* The lesion is located on or in an area of visible scarring
* The lesion contains foreign matter (e.g., tattoo, splinter, marker)

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes