Focus of Study: Patients With Suspicion of Melanoma Clinical Trial
Official title:
Evaluation of the Clinical Utility of Electrical Impedance Spectroscopy in Normal Clinical Practice at Hospital Setting
The purpose of this clinical study is to evaluate the clinical utility of the Nevisense in normal clinical practice, i.e. the potential effect of implementing Nevisense in clinical decision making (Human vs Human & Machine) based on Nevisense measurement at time of biopsy decision.
This is a multi-center, prospective, blinded clinical study designed to evaluate clinical
utility of Nevisense in normal clinical practice, i.e. the potential effect of implementing
Nevisense in clinical decision making (Human vs Human & Machine) based on Nevisense
measurement after biopsy decision. The study enrollment will continue until minimum of 180
subjects are enrolled in the study. Up to 3 US university/hospital investigational sites will
participate in this study. Biopsying clinician or the investigators from the clinical
practices of physicians participating in the study will perform the patient and lesion
assessment for biopsy as standard of care at the clinic.
Study subjects will be recruited from the clinical practices of physicians participating as
investigators in this study. Biopsying clinicians provide their assessment to whether s/he
would have sent the lesion(s) for biopsy had s/he known the EIS information beforehand .
Thereafter an evaluation of the suspicious lesion with the Nevisense will be performed
followed by a biopsy of the lesion. The biopsied lesion will be subjected to histological
analysis.
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