Instrument Precision Study for Validation of PIPS 5.1
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 399
- 试验地点
- 1
- 主要终点
- Presence or absence of features
研究概览
简要总结
This study is designed to evaluate the instrument precision of the device for its proposed intended use in sub-studies: intra-system and inter-system. The precision within a system will be evaluated on three systems by three pathologists at one site. Specific features will be selected on glass slides, which will then be scanned. On the whole slide images field of views will be created including the features. In the reading phase three pathologists will read the field of views and record which features they observe.
详细描述
This study is designed to evaluate the instrument precision of the device for its proposed intended use in sub-studies: intra-system and inter-system. Each sub-study will have three phases: enrollment, preparation and reading.
Per sub-study the precision of the device will be based on three reading pathologists' assessments and identification of specific clinically relevant histopathologic "features" that are encountered in formalin-fixed, paraffin-embedded (FFPE) hematoxylin and eosin (H&E) slides. Examples of these features are eosinophils, plasma cells, goblet cells, foreign body giant cells, etc. Three magnifications are used in this study: 10x, 20x and 40x. These magnifications represent the magnifications typically used in routine clinical practice. There will be seven different study features per magnification. In total twenty-one features will be selected, with each feature selected from at least three different organs, to ensure that multiple tissue types are investigated.
Precision will be assessed in sub-studies: intra-system and inter-system.
- In the intra-system study the precision within a system will be evaluated on three systems by three pathologists at one site;
- In the inter-system study the precision between systems will be evaluated on three systems by three pathologists at one site;
Enrollment:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Left-over specimens from subjects who already received their diagnosis and have received their treatment in accordance with the standard of care
- •H&E glass coverslipped slides with human tissue obtained via surgical pathology
- •Selected slides fulfill the quality checks according to the IfU
- •Selected slides must be at least one year since accessioning
- •Selected slides and FOVs must contain a study feature that is:
- •In it's natural environment (on slide and FOV)
- •Not equivocal (on slide and FOV)-
排除标准
- •Selected slides contain indelible markings
- •Selected slides contain damaged tissue
- •More than one slide was selected for a patient (only one slide may be enrolled per patient).
结局指标
主要结局
Presence or absence of features
时间窗: 1 day
Each reading pathologist will record the presence of listed features on the checklist. The results will be used for deriving an agreement rate between repeated readings from the same reading pathologist over all enrolled (i.e. selected and validated) features.
次要结局
未报告次要终点