Post-Approval Study of MelaFind

Stopped early

Conditions studied: Melanoma

In brief

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.

Key facts

Study ID

NCT01700114

Run by

MELA Sciences, Inc.

People needed

487

Starts

2012-11-01

Expected to finish

2016-01-01

Last updated by the study team

2016-03-11

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• AboutSkin Dermatology and DermSurgery — Englewood, Colorado, United States
• Dermatology Associates of Tallahassee — Tallahassee, Florida, United States
• The Johns Hopkins University — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• The Dermatology Group, P.C. — Verona, New Jersey, United States
• University Hospitals Case Medical Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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