Evaluation of Nevisense as Support Tool for the Diagnose of Keratinocyte Skin Cancer
Evaluation of the Clinical Utility of a New Diagnostic Support Tool, Based on Electrical Impedance Spectroscopy (NEVISENSE), for Keratinocyte Skin Cancer
SciBase AB
150 participants
Jul 13, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria1
- 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 Criteria11
- 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
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06064019