Melanoma
Conditions
Keywords
Pigmented Skin Lesions, Dermatology, Skin Cancer, Melanoma, MelaFind
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.
Interventions
DEVICEMelaFind
The device is used when a dermatologist chooses to obtain additional information on atypical skin lesions for a decision to biopsy.
Sponsors
MELA Sciences, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relative sensitivity comparing enrolling dermatologists after MelaFind use with enrolling dermatoligsts if MelaFind were not available | 6 years |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed