Post-Approval Study of MelaFind

Study Overview
=================
Brief 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.

Detailed 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.

Official Title
-----------------
Post-Approval Study of MelaFind

Conditions
-----------------
Melanoma

Intervention / Treatment
-----------------
* Device: MelaFind


Participation Criteria
=================
Eligibility Criteria
-----------------
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)
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: MelaFind|The device is used when a dermatologist chooses to obtain additional information on atypical skin lesions for a decision to biopsy.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative sensitivity comparing enrolling dermatologists after MelaFind use with enrolling dermatoligsts if MelaFind were not available |  | 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe characteristics of patients and lesions with MelaFind, the experience of using MelaFind, distribution of test results, and details on biopsied lesions. |  | 6 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pigmented Skin Lesions, Dermatology, Skin Cancer, Melanoma, MelaFind