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NCT Number: NCT06064019

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

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.

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Key information

Conditions

Keratinocyte Skin Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CentroDerm

Wuppertal, Germany

Location status: Recruiting

Location contact

Lutz Schmitz, Priv.-Doz.Dr.med

SUB_INVESTIGATOR

Thomas Dirschka, Prof.Dr.med.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nevisense

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.

Primary outcomes

  1. Nevisense Sensitivity and Specificity

    Time frame: 1 year

    This study has two primary endpoints:

    • Sensitivity ≥ 0.90
    • Sensitivity + Specificity > 1.0

    Sensitivity is the proportion of correctly identified cases of KC. Specificity is the proportion of correctly identified cases of non-KC

Study contacts

Contact information is provided by the study sponsor or research team.

Per Svedenhag

CONTACT

[email protected]

+46 8410 620 01

Sponsors and collaborators

Lead sponsor

SciBase AB

Other

Registry information

Official study title

Evaluation of the Clinical Utility of a New Diagnostic Support Tool, Based on Electrical Impedance Spectroscopy (NEVISENSE), for Keratinocyte Skin Cancer

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 3, 2023
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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