Evaluation of Nevisense as Support Tool for the Diagnose of Keratinocyte Skin Cancer
NCT06064019 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2024-12-11
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.
Conditions
- Keratinocyte Skin Cancer
Interventions
- 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.
Sponsors & Collaborators
-
SciBase AB
lead OTHER
Principal Investigators
-
Thomas Dirschka, Prof. Dr. med. · CentroDerm GmbH
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-07-13
- Primary Completion
- 2025-02-28
- Completion
- 2025-02-28
Countries
- Germany
Study Locations
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