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Trial record 2 of 12 for:    electrical impedance spectroscopy

Clinical Utility of Electrical Impedance Spectroscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04161742
Recruitment Status : Not yet recruiting
First Posted : November 13, 2019
Last Update Posted : November 13, 2019
Information provided by (Responsible Party):
SciBase AB

Brief 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.

Condition or disease Intervention/treatment Phase
Focus of Study: Patients With Suspicion of Melanoma Device: Nevisense Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

Intervention Details:
  • Device: Nevisense
    Nevisense measures electrical impedance of skin lesions and provides an output called the electrical impedance spectroscopy (EIS) score

Primary Outcome Measures :
  1. Number needed to biopsy [ Time Frame: 1 day ]
    The primary study outcome is the number needed to biopsy to detect a single melanoma case.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • The lesion(s) meet criteria for Nevisense evaluation.
  • Lesions that present with unclear clinical presentation to allow for clinical diagnosis of benign or minimally dysplastic nevus (nevi) -Thus, necessitating a biopsy.
  • Lesions within Nevisense indication for use: Nevisense is indicated for use on cutaneous lesions with one or more clinical or historical characteristics of melanoma, when a dermatologist chooses to obtain additional information when considering biopsy. Nevisense should not be used on clinically obvious melanoma. The Nevisense result is one element of the overall clinical assessment. The output of Nevisense should be used in combination with clinical and historical signs of melanoma to obtain additional information prior to a decision to biopsy. Nevisense is indicated only for use on:

    • primary skin lesions with a diameter between 2 mm and 20 mm;
    • lesions that are accessible by the Nevisense probe;
    • lesions where the skin is intact (i.e. non-ulcerated or non-bleeding lesions);
    • lesions that do not contain a scar or fibrosis consistent with previous trauma;
    • lesions not located in areas of psoriasis, eczema, acute sunburn or similar skin conditions;
    • lesions not in hair-covered areas;
    • lesions which do not contain foreign matter;
    • lesions not on special anatomic sites (i.e. not for use on acral skin, genitalia, eyes, mucosal areas).

Exclusion Criteria:

  • Subjects who fail to provide informed consent
  • Study subjects with underlying medical disease which may alter ability to diagnose clinically or inhibit Nevisense from collecting data

Information from the National Library of Medicine

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 identifier (NCT number): NCT04161742

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Contact: Laura Ferris, MD +1 412-647-4200 ferrlk@UPMC.EDU

Sponsors and Collaborators
SciBase AB
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Principal Investigator: Laura Ferris, MD University of Pittsburgh
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Responsible Party: SciBase AB Identifier: NCT04161742    
Other Study ID Numbers: FG-001
First Posted: November 13, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas