Post-Approval Study of MelaFind

This study has been terminated.
(FDA withdrew requirement to complete study)
Sponsor:
Information provided by (Responsible Party):
MELA Sciences, Inc.
ClinicalTrials.gov Identifier:
NCT01700114
First received: October 2, 2012
Last updated: March 10, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention
Melanoma
Device: MelaFind

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Approval Study of MelaFind

Resource links provided by NLM:


Further study details as provided by MELA Sciences, Inc.:

Primary Outcome Measures:
  • Relative sensitivity comparing enrolling dermatologists after MelaFind use with enrolling dermatoligsts if MelaFind were not available [ Time Frame: 6 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To describe characteristics of patients and lesions with MelaFind, the experience of using MelaFind, distribution of test results, and details on biopsied lesions. [ Time Frame: 6 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA
pathology slides of biopsied tissue

Enrollment: 487
Study Start Date: November 2012
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: MelaFind
    The device is used when a dermatologist chooses to obtain additional information on atypical skin lesions for a decision to biopsy.
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.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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 six states in which MelaFind is commercially available. Some of the sites will be located in urban settings, and some 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.

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01700114

Locations
United States, Colorado
AboutSkin Dermatology and DermSurgery
Englewood, Colorado, United States, 80113
United States, Florida
Dermatology Associates of Tallahassee
Tallahassee, Florida, United States, 32308
United States, Maryland
The Johns Hopkins University
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New Jersey
The Dermatology Group, P.C.
Verona, New Jersey, United States, 07044
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
MELA Sciences, Inc.
Investigators
Principal Investigator: Armand Cognetta, MD Dermatology Associates of Tallahassee
Principal Investigator: Timothy Wang, MD The John's Hopkins University
Principal Investigator: Meg Gerstenblith, MD University Hospital Case Medical Center
Principal Investigator: Robert Nossa, MD The Dermatology Group, P.C
Principal Investigator: Arthur Sober, MD Massachusetts General Hospital
Principal Investigator: Joel Cohen, MD AboutSkin Dermatology and DermSurgery
  More Information

Responsible Party: MELA Sciences, Inc.
ClinicalTrials.gov Identifier: NCT01700114     History of Changes
Other Study ID Numbers: Protocol 20111 
Study First Received: October 2, 2012
Last Updated: March 10, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by MELA Sciences, Inc.:
Pigmented Skin Lesions
Dermatology
Skin Cancer
Melanoma
MelaFind

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on August 23, 2016