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Evaluation of Nevisense as Support Tool for the Diagnose of Keratinocyte Skin Cancer

NCT ID: NCT06064019

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-13

Study Completion Date

2025-02-28

Brief Summary

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This is a prospective study to assess efficacy of the Nevisense device in identifying keratinocyte skin cancer (KC) in patients suspected of having skin cancer based on the initial physician's assessment.

All skin lesions with a suspicion of Basal cell carcinoma (BCC), Invasive Squamos cell Carcinoma (iSCC), Bowen's disease (BD) or actinic keratosis (AK) and destined for excision or biopsy for further histopathological analysis will be considered for inclusion in the study.

Detailed Description

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Conditions

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Keratinocyte Skin Cancer

Keywords

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Electrical Impedance Spectroscopy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Nevisense

This will be a prospective investigator-initiated study to evaluate the accuracy of Nevisense for KC. First evaluation steps include dermatologist's clinical examination (visual inspection) and videodermoscopy. In those cases where the routine diagnostic procedures given above identify any suspicion of a KC, a Nevisense measurement is to be conducted after examination of inclusion and exclusion criteria. Thereafter, surgical excision and histopathologic examination follow.

All skin lesions with a suspicion of BCC, iSCC, BD or AK and destined for excision or biopsy for further histopathological analysis will be considered for inclusion in the study. A maximum of three lesions per patient will be allowed for the study. The study aims to enrol 250 lesions in total.

Group Type OTHER

Nevisense

Intervention Type DEVICE

The Nevisense system is based on Electrical Impedance Spectroscopy (EIS). EIS is a measure of the overall resistance within a skin tissue, at alternating currents of various frequencies. Since skin tissues have different electrical properties depending on cell structure and medical conditions, the resulting electrical impedance spectra will reflect the properties of the skin tissue.

Interventions

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Nevisense

The Nevisense system is based on Electrical Impedance Spectroscopy (EIS). EIS is a measure of the overall resistance within a skin tissue, at alternating currents of various frequencies. Since skin tissues have different electrical properties depending on cell structure and medical conditions, the resulting electrical impedance spectra will reflect the properties of the skin tissue.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All male or female patients of any ethnicity, ≥ 18 years with skin lesions of a clinical uncertain diagnosis suspicious for KC (such as BCC, iSCC, BD or AK)

Exclusion Criteria

* Metastases of recurrent lesions
* Lesion located on acral skin, e.g. sole or palm
* Lesion located on areas of scars, crusts, psoriasis or similar skin conditions
* Lesion on hair-covered areas, e.g. scalp, beards, moustaches
* Lesion located on genitalia
* Lesion located in an area that has been previously biopsied or subjected to any kind of surgical intervention or traumatized
* Lesion located on mucosal surfaces
* Lesion with foreign matter, e.g. tattoo or splinter
* Lesion and / or reference located on acute sunburn
* Skin surface not measurable, e.g. lesion on a stalk
* Skin surface not accessible, e.g. inside ears, under nails
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SciBase AB

OTHER

Sponsor Role lead

Responsible Party

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Thomas Dirschka

Prof Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Dirschka, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

CentroDerm GmbH

Locations

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CentroDerm

Wuppertal, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Per Svedenhag

Role: CONTACT

Phone: +46 8410 620 01

Email: [email protected]

Other Identifiers

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EIS-KC001

Identifier Type: -

Identifier Source: org_study_id