Status:
COMPLETED
Evaluation of Pigmented Skin Lesions With MelaFind(R) System
Lead Sponsor:
MELA Sciences, Inc.
Conditions:
Melanoma
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
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 e...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
1383 Patients enrolled
Trial Details
Trial ID
NCT00434057
Start Date
January 1 2007
End Date
July 1 2008
Last Update
February 14 2012
Active Locations (2)
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1
Skin and Cancer Associates
Plantation, Florida, United States, 33324
2
Dermatology Associates of Tallahassee
Tallahassee, Florida, United States, 32317