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

Rekrutierend

NCT-Nummer:
NCT06064019

Studienbeginn:
Juli 2023

Letztes Update:
22.04.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Skin Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
SciBase AB

Collaborator:
-

Studienleiter

Thomas Dirschka, Prof. Dr. med.
Principal Investigator
CentroDerm GmbH

Kontakt

Per Svedenhag
Kontakt:
Phone: +46 8410 620 01
E-Mail: per.svedenhag@scibase.com» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

CentroDerm
Wuppertal
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps

Studien-Informationen

Brief 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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

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

Geprüfte Regime

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.

Quelle: ClinicalTrials.gov