Clinical Utility of Electrical Impedance Spectroscopy
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|ClinicalTrials.gov Identifier: NCT04161742|
Recruitment Status : Not yet recruiting
First Posted : November 13, 2019
Last Update Posted : November 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Focus of Study: Patients With Suspicion of Melanoma||Device: Nevisense||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Clinical Utility of Electrical Impedance Spectroscopy in Normal Clinical Practice at Hospital Setting|
|Estimated Study Start Date :||December 2019|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||August 2020|
- Device: Nevisense
Nevisense measures electrical impedance of skin lesions and provides an output called the electrical impedance spectroscopy (EIS) score
- Number needed to biopsy [ Time Frame: 1 day ]The primary study outcome is the number needed to biopsy to detect a single melanoma case.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04161742
|Contact: Laura Ferris, MD||+1 412-647-4200||ferrlk@UPMC.EDU|
|Principal Investigator:||Laura Ferris, MD||University of Pittsburgh|