Ignite Creation Date:
2024-05-06 @ 7:09 AM
Last Modification Date:
2024-10-26 @ 11:44 AM
Study NCT ID:
NCT02470572
Status:
UNKNOWN
Last Update Posted:
2016-03-28
First Post:
2015-06-04
Brief Title:
Evaluation of the Omnyx Integrated Digital Pathology System in the Primary Diagnosis of Surgical Pathology Specimens
Sponsor:
Omnyx LLC
Organization:
Omnyx LLC
Study Overview
Official Title:
Evaluation of the Omnyx Integrated Digital Pathology System in the Primary Diagnosis of Surgical Pathology Specimens
Status:
UNKNOWN
Status Verified Date:
2016-03
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
PrimeDx
Brief Summary:
A multi-site randomized-read order retrospective paired-design evaluation of the Omnyx Integrated Digital Pathology IDP system with de-identified and previously signed-out cases from all major organ systems Pathologist will read and diagnose cases on a conventional light microscope and on the Omnyx IDP system for Whole Slide Images WSI with a randomized read order College of American Pathologists CAP cancer protocol checklists will be used to capture diagnostic reporting
Diagnoses rendered by site Reading Pathologists will be captured on CAP checklists and compared directly to the Ground Truth GT diagnosis for both modalities
Diagnoses rendered by site Reading Pathologists will be captured on CAP checklists and compared directly to the Ground Truth GT diagnosis for both modalities
Detailed Description:
Following the FDA issued guidance document Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable- 2006 the specimens are surgical pathology samples from leftover human specimens from clinical cases archived and previously signed-out across the majority of surgical pathology subspecialties
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