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Trial Title:
Evaluation of Nevisense as Support Tool for the Diagnose of Keratinocyte Skin Cancer
NCT ID:
NCT06064019
Condition:
Keratinocyte Skin Cancer
Conditions: Official terms:
Skin Neoplasms
Conditions: Keywords:
Electrical Impedance Spectroscopy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Nevisense
Description:
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.
Arm group label:
Nevisense
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
CentroDerm
Address:
City:
Wuppertal
Country:
Germany
Status:
Recruiting
Investigator:
Last name:
Thomas Dirschka, Prof.Dr.med.
Email:
Principal Investigator
Investigator:
Last name:
Lutz Schmitz, Priv.-Doz.Dr.med
Email:
Sub-Investigator
Start date:
July 13, 2023
Completion date:
September 2024
Lead sponsor:
Agency:
SciBase AB
Agency class:
Other
Source:
SciBase AB
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06064019
