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

ConditionKeratinocyte Skin Cancer

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorSciBase AB

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

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.

Treatment groups

150 Participants

are divided into 1 treatment group

Group A: NevisenseOther 1 intervention

Trial outcomes

Primary outcomes

Nevisense Sensitivity and Specificity

This study has two primary endpoints: 1. Sensitivity ≥ 0.90 2. 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

Time frame

1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

SciBase AB

Lead sponsor

CentroDerm GmbH

Sponsor institution

Source ClinicalTrials.gov

Apply now