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A Prospective, Non-controlled, Multicenter Clinical Study to Evaluate the Diagnostic Accuracy of the Stepwise Two Photon Excited Melanin Fluorescence of Potentially Malignant Pigmented Lesions as Compared to Histopathological Diagnosis
All patients will undergo dermoscopic diagnosis and be documented with a video image storing. The diagnosis based on dermoscopy will be immediately documented. Then, as a second diagnostic procedure, fluorescence diagnostics based on the two photon excitation from a dye-laser will be performed. The classification as non-melanoma or malignant melanoma by the medical device LIMES will also be documented immediately. Afterwards, the lesion will be excised and undergo histopathologic examination by the respective histopathologist of the participating centers. The histopathologic diagnosis will serve as gold standard for subsequent evaluations of the diagnostic accuracy.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Dept. of Dermatology, Charité
Berlin, Germany
Dept. of Dermatology, University Hospital
Heidelberg, Germany
Dept. of Dermatology, University Hospital
Tübingen, Germany
Start Date
August 1, 2014
Primary Completion Date
July 1, 2016
Completion Date
December 1, 2016
Last Updated
May 3, 2017
500
ACTUAL participants
LIMES
DEVICE
Lead Sponsor
University Hospital Tuebingen
Collaborators
NCT05039801
NCT06066138
Data Source & Attribution
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