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Clinical Utility of Electrical Impedance Spectroscopy

Primary Purpose

Focus of Study: Patients With Suspicion of Melanoma

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nevisense
Sponsored by
SciBase AB
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Focus of Study: Patients With Suspicion of Melanoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Number needed to biopsy
    The primary study outcome is the number needed to biopsy to detect a single melanoma case.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 5, 2019
    Last Updated
    November 12, 2019
    Sponsor
    SciBase AB
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04161742
    Brief Title
    Clinical Utility of Electrical Impedance Spectroscopy
    Official Title
    Evaluation of the Clinical Utility of Electrical Impedance Spectroscopy in Normal Clinical Practice at Hospital Setting
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2019 (Anticipated)
    Primary Completion Date
    June 2020 (Anticipated)
    Study Completion Date
    August 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    SciBase AB

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Focus of Study: Patients With Suspicion of Melanoma

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    180 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    Nevisense
    Intervention Description
    Nevisense measures electrical impedance of skin lesions and provides an output called the electrical impedance spectroscopy (EIS) score
    Primary Outcome Measure Information:
    Title
    Number needed to biopsy
    Description
    The primary study outcome is the number needed to biopsy to detect a single melanoma case.
    Time Frame
    1 day

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Laura Ferris, MD
    Phone
    +1 412-647-4200
    Email
    ferrlk@UPMC.EDU
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Laura Ferris, MD
    Organizational Affiliation
    University of Pittsburgh
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    24841846
    Citation
    Malvehy J, Hauschild A, Curiel-Lewandrowski C, Mohr P, Hofmann-Wellenhof R, Motley R, Berking C, Grossman D, Paoli J, Loquai C, Olah J, Reinhold U, Wenger H, Dirschka T, Davis S, Henderson C, Rabinovitz H, Welzel J, Schadendorf D, Birgersson U. Clinical performance of the Nevisense system in cutaneous melanoma detection: an international, multicentre, prospective and blinded clinical trial on efficacy and safety. Br J Dermatol. 2014 Nov;171(5):1099-107. doi: 10.1111/bjd.13121. Epub 2014 Oct 19.
    Results Reference
    background
    PubMed Identifier
    28421597
    Citation
    Rocha L, Menzies SW, Lo S, Avramidis M, Khoury R, Jackett L, Guitera P. Analysis of an electrical impedance spectroscopy system in short-term digital dermoscopy imaging of melanocytic lesions. Br J Dermatol. 2017 Nov;177(5):1432-1438. doi: 10.1111/bjd.15595. Epub 2017 Oct 11.
    Results Reference
    background

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    Clinical Utility of Electrical Impedance Spectroscopy

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