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

Last updated: December 6, 2024
Sponsor: SciBase AB
Overall Status: Active - Recruiting

Phase

N/A

Condition

Skin Cancer

Treatment

Nevisense

Clinical Study ID

NCT06064019
EIS-KC001
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All male or female patients of any ethnicity, ≥ 18 years with skin lesions of aclinical uncertain diagnosis suspicious for KC (such as BCC, iSCC, BD or AK)

Exclusion

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 kindof 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

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: Nevisense
Phase:
Study Start date:
July 13, 2023
Estimated Completion Date:
February 28, 2025

Connect with a study center

  • CentroDerm

    Wuppertal,
    Germany

    Active - Recruiting

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