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

Keratinocyte Skin Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06064019
• Other study ID #: EIS-KC001
• Status: Recruiting
• Phase: N/A
• Start date: July 13, 2023
• Est. completion date: September 2024

Study information

• Verified date: April 2024
• Source: SciBase AB
• Contact: Per Svedenhag
• Phone: +46 8410 620 01
• Email: per.svedenhag[@]scibase.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Keratinocyte Skin Cancer
• Skin Neoplasms

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Germany	CentroDerm	Wuppertal

Sponsors (1)

Lead Sponsor	Collaborator
SciBase AB

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nevisense Sensitivity and Specificity	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	1 year