Using Nevisense to help diagnose keratinocyte skin cancer
Official title: Evaluation of the Clinical Utility of a New Diagnostic Support Tool, Based on Electrical Impedance Spectroscopy (NEVISENSE), for Keratinocyte Skin Cancer
Run by SciBase AB · NCT06064019 · Data updated 2026-11-12
This study is testing if the Nevisense device can help doctors better identify keratinocyte skin cancer in patients with suspicious skin lesions before they have surgery or a biopsy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | SciBase AB Academic / other |
| Locations | 1 site (Wuppertal) |
| Status | Recruiting |
| Started | July 13, 2023 |
| Main results expected | February 2025 |
| Study ends | February 2025 |
| Registry record updated | December 11, 2024 |
| Trial ID | NCT06064019 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with skin lesions that are clinically uncertain and suspected of being keratinocyte skin cancer.
✕Probably not a fit
Patients with lesions that have metastasized, are located in specific excluded areas, or have been previously treated may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective study evaluates the effectiveness of the Nevisense device in identifying keratinocyte skin cancer in patients suspected of having skin cancer based on initial assessments by physicians. The study includes patients with skin lesions that are clinically uncertain and suspicious for conditions such as basal cell carcinoma, invasive squamous cell carcinoma, Bowen's disease, or actinic keratosis. Participants will undergo evaluation with the Nevisense device prior to any excision or biopsy for further histopathological analysis.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of diagnosing keratinocyte skin cancer, leading to timely and appropriate treatment for patients.
How similar studies have gone: While the use of electrical impedance spectroscopy in skin cancer diagnosis is a relatively novel approach, similar studies have shown promising results in improving diagnostic accuracy.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
CentroDerm
Wuppertal, Germany Recruiting
Study contacts
- Principal investigator: Thomas Dirschka, Prof. Dr. med. — CentroDerm GmbH
- Study coordinator: Per Svedenhag
- Email: per.svedenhag@scibase.com
- Phone: +46 8410 620 01
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.