Evaluation of the Omnyx™ Integrated Digital Pathology System in the Primary Diagnosis of Surgical Pathology Specimens

Not Applicable

• Conditions: Primary Diagnosis of Surgical Pathology Specimens
• Interventions: Other: Omnyx™ IDP system; Other: Conventional light microscope

• Registration Number: NCT02470572
• Lead Sponsor: Omnyx, LLC

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.

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 Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-04
• Study First Submitted QC: 2015-06-11
• Study First Posted: 2015-06-12
• Status Verified: 2016-03
• Primary Completion: 2016-03
• Last Update Submitted: 2016-03-24
• Last Update Posted: 2016-03-28
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• All surgical pathology samples from pre-identified list provided by FDA

Exclusion Criteria

• Gross evaluation only specimens (including hardware and specimens that do not require microscopic review for diagnosis)
• Immunofluorescence specimens
• Fluid-based specimens
• Intraoperative consultation specimens only (frozen preparation)
• Specimens from which a slide(s) fails quality control according to user manuals and training and issue(s) cannot be remediated at the time of procurement and over-labeling; this includes having too many labels such that slide damage or scanner failure is likely (as outlined in Omnyx user manuals).
• Specimens for which any slide (other than a blank) that should be in the case part cannot be located

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Omnyx™ IDP system	Omnyx™ IDP system	Omnyx™ IDP system for Whole Slide Images (WSI)
Conventional light microscope	Conventional light microscope	conventional light microscope

Primary Outcome Measures

Name	Time	Method
Diagnosis of surgical pathology	1 Year	Demonstrate the effectiveness of the Omnyx™ IDP system is non-inferior to the Diagnostic Reference Standard glass diagnosis in routine surgical pathology cases.