Status:
RECRUITING
Evaluation of Nevisense as Support Tool for the Diagnose of Keratinocyte Skin Cancer
Lead Sponsor:
SciBase AB
Conditions:
Keratinocyte Skin Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 assessm...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06064019
Start Date
July 13 2023
End Date
February 1 2025
Last Update
December 11 2024
Active Locations (1)
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1
CentroDerm
Wuppertal, Germany