Post-Approval Study of MelaFind

Post-Approval Study of MelaFind

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.

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.

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)