Ignite Creation Date:
2024-05-06 @ 7:35 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06064019
Status:
RECRUITING
Last Update Posted:
2024-04-22
First Post:
2023-09-11
Brief Title:
Evaluation of Nevisense as Support Tool for the Diagnose of Keratinocyte Skin Cancer
Sponsor:
SciBase AB
Organization:
SciBase AB
Study Overview
Official Title:
Evaluation of the Clinical Utility of a New Diagnostic Support Tool Based on Electrical Impedance Spectroscopy NEVISENSE for Keratinocyte Skin Cancer
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 physicians assessment
All skin lesions with a suspicion of Basal cell carcinoma BCC Invasive Squamos cell Carcinoma iSCC Bowens disease BD or actinic keratosis AK and destined for excision or biopsy for further histopathological analysis will be considered for inclusion in the study
All skin lesions with a suspicion of Basal cell carcinoma BCC Invasive Squamos cell Carcinoma iSCC Bowens disease BD or actinic keratosis AK and destined for excision or biopsy for further histopathological analysis will be considered for inclusion in the study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None