Post-Approval Study of MelaFind

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by MELA Sciences, Inc.
Sponsor:
Information provided by (Responsible Party):
MELA Sciences, Inc.
ClinicalTrials.gov Identifier:
NCT01700114
First received: October 2, 2012
Last updated: June 20, 2014
Last verified: June 2014

October 2, 2012
June 20, 2014
November 2012
December 2014   (final data collection date for primary outcome measure)
Relative sensitivity of enrolling dermatologists after MelaFind use and enrolling dermatologists if MelaFind were not available. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01700114 on ClinicalTrials.gov Archive Site
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Post-Approval Study of MelaFind
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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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

All patients of any age, race, ethnicity, or gender, presenting with pigmented skin lesions that that meet the Indications for Use and Lesion Inclusion and Exclusion Criteria, including signing the Informed Consent Form, are eligible to participate in this study. This single-arm study has one study group consisting of eligible lesions on eligible patients.

Up to six clinical sites in the US will participate in this study, one in each of the first six states in which MelaFind is commercially available. Three of the sites will be located in urban settings, and three will be located in a suburban or rural setting. At least 50% of the sites will new, i.e., they did not participate in the MelaFind pivotal study. Some sites will be academic centers and some private practices.

Melanoma
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
720
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December 2014   (final data collection date for primary outcome measure)

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)
Both
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Yes
Contact: Nara Chhua 914-591-3783 ext 743 nchhua@melasciences.com
United States
 
NCT01700114
Protocol 20111
No
MELA Sciences, Inc.
MELA Sciences, Inc.
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MELA Sciences, Inc.
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP