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

Omnyx

Status: Unknown

Conditions: Primary Diagnosis of Surgical Pathology Specimens

Treatments: Other: Conventional light microscope; Other: Omnyx™ IDP system

Study type: Interventional

Funder types: Industry

Identifiers

NCT02470572

CD-0010

Details and patient eligibility

About

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.

Full 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

Enrollment: 1,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,000 participants in 2 patient groups, including a placebo group

Omnyx™ IDP system

Active Comparator group

Description:

Omnyx™ IDP system for Whole Slide Images (WSI)

Treatment:

Other: Omnyx™ IDP system

Conventional light microscope

Placebo Comparator group

Description:

conventional light microscope

Treatment:

Other: Conventional light microscope