Evaluation of the Omnyx™ Integrated Digital Pathology System in the Primary Diagnosis of Surgical Pathology Specimens
试验速览
- 阶段
- 不适用
- 发起方
- Omnyx, LLC
- 入组人数
- 1,000
- 主要终点
- Diagnosis of surgical pathology
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All surgical pathology samples from pre-identified list provided by FDA
排除标准
- •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
结局指标
主要结局
Diagnosis of surgical pathology
时间窗: 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.
次要结局
未报告次要终点