NCT04161742

Clinical Utility of Electrical Impedance Spectroscopy

Evaluation of the Clinical Utility of Electrical Impedance Spectroscopy in Normal Clinical Practice at Hospital Setting

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: SciBase AB · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Focus of Study: Patients With Suspicion of Melanoma

Interventions

Type	Name	Description
DEVICE	Nevisense	Nevisense measures electrical impedance of skin lesions and provides an output called the electrical impedance spectroscopy (EIS) score

Timeline

• Start date: 2019-12-01
• Primary completion: 2020-06-01
• Completion: 2020-08-01
• First posted: 2019-11-13
• Last updated: 2019-11-13