Ignite Creation Date:
2024-10-25 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06654999
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-22
Brief Title:
DERM Precision Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Precision Study to Demonstrate the Repeatability and Reproducability of DERM Outputs
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
DERM is a Medical Device that uses artificial intelligence to help doctors check if a skin lesion might be cancerous It works by analysing close-up pictures of skin lesions taken with a smartphone
This study aims to see how precice the output of DERM is we want to know if different people taking pictures of the same lesion repeatability or using different devices specifically an iPhone 11 with a special lens to take the pictures reproducibility affects the output of DERM
We will involve adults with at least one skin lesion that doctors are checking for cancer as part of their standard care to take part Suitable lesions will be photographed three times each by three different people using three different devices each image being checked for good image quality as it is captured Images will then be transferred to DERM where theyll be analysed
The DERM output wont be shared with the patients or doctors involved in the study The patients will continue to have their skin lesion biopsyexcised in accordance with standard of care Their diagnosis will be collected and compared to the output from DERM
This study aims to see how precice the output of DERM is we want to know if different people taking pictures of the same lesion repeatability or using different devices specifically an iPhone 11 with a special lens to take the pictures reproducibility affects the output of DERM
We will involve adults with at least one skin lesion that doctors are checking for cancer as part of their standard care to take part Suitable lesions will be photographed three times each by three different people using three different devices each image being checked for good image quality as it is captured Images will then be transferred to DERM where theyll be analysed
The DERM output wont be shared with the patients or doctors involved in the study The patients will continue to have their skin lesion biopsyexcised in accordance with standard of care Their diagnosis will be collected and compared to the output from DERM
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None