NCT01700114|Terminated
Study Stopped
FDA withdrew requirement to complete study
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FDA withdrew requirement to complete study
Sponsor study identifier
observational
487
1 country
6
Study Start
November 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2016
Actual (reported)Study Completion
January 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2, 2012
Actual (reported)October 4, 2012
Actual (reported)November 2012
Date type not reportedThis date has not been verified as actual or estimated.
January 2016
Actual (reported)January 2016
Actual (reported)Relative sensitivity comparing enrolling dermatologists after MelaFind use with enrolling dermatoligsts if MelaFind were not available
6 years
To describe characteristics of patients and lesions with MelaFind, the experience of using MelaFind, distribution of test results, and details on biopsied lesions.
6 years
The device is used when a dermatologist chooses to obtain additional information on atypical skin lesions for a decision to biopsy.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
AboutSkin Dermatology and DermSurgery
Englewood, Colorado, 80113, United States
Dermatology Associates of Tallahassee
Tallahassee, Florida, 32308, United States
The Johns Hopkins University
Baltimore, Maryland, 21205, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
The Dermatology Group, P.C.
Verona, New Jersey, 07044, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
pathology slides of biopsied tissue
Armand Cognetta, MD
Dermatology Associates of Tallahassee
Timothy Wang, MD
The John's Hopkins University
Meg Gerstenblith, MD
University Hospitals Cleveland Medical Center
Robert Nossa, MD
The Dermatology Group, P.C
487 participants (actual enrollment reported by the registry).
First Submitted
October 2, 2012
First Posted
October 4, 2012
Study Start
November 2012
Date type not reportedThis date has not been verified as actual or estimated.
Doxycycline, Temozolomide and Ipilimumab in Melanoma
Contact the study team to confirm eligibility.
Arthur Sober, MD
Massachusetts General Hospital
Joel Cohen, MD
AboutSkin Dermatology and DermSurgery
Primary Completion
January 2016
Actual (reported)Study Completion
January 2016
Actual (reported)Last Updated
March 11, 2016
Record last verified: 2016-03
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Source: ClinicalTrials.gov.
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