Ignite Creation Date:
2024-07-17 @ 10:59 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06463860
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-11
Brief Title:
Multi-Center Study to Evaluate the Performance of DermDx for Primary Care Physicians in the Detection of Skin Cancers
Sponsor:
MetaOptima Technology Inc
Organization:
MetaOptima Technology Inc
Study Overview
Official Title:
Retrospective Multi-Center Study to Evaluate the Performance of DermDx as an Adjunctive Tool for Primary Care Physicians in the Detection of Skin Cancers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
The proposed study is a pivotal multi-center retrospective reader study designed to determine whether the use of DermDx as a concurrent reading aid improves the performance of primary care physicians PCPs in diagnosing skin cancers
Detailed Description:
The proposed study is a pivotal multi-center retrospective reader study designed to determine whether the use of DermDx as a concurrent reading aid improves the performance of primary care physicians PCPs in diagnosing skin cancers
DermDx is a deep learning-based algorithm that analyzes lesion images to detect skin cancer The software does not have dedicated hardware and can accept as input any dermoscopic images taken with commercial dermoscopes
Because the study is designed to investigate the change in the performance of the PCPs before and after seeing the device output a single-arm study design has been used
DermDx is a deep learning-based algorithm that analyzes lesion images to detect skin cancer The software does not have dedicated hardware and can accept as input any dermoscopic images taken with commercial dermoscopes
Because the study is designed to investigate the change in the performance of the PCPs before and after seeing the device output a single-arm study design has been used
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None