NCT04955704

Performance Study for InferRead CT Pneumonia.AI

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 423 (estimated)
• Sponsor: Infervision · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

A retrospective, blineded, multicenter study of the InferRead CT Pneumonia.AI to evaluate the performance in identifying non-contrast chest CT scans containing pneumonia findings.

Detailed description

This is a retrospective, blinded, multicenter study for the InferRead CT Pneumonia.AI. The primary endpoint will evaluate the software's performance in identifying non-contrast chest CT scans containing pneumonia. It will evaluate InferRead CT Pneumonia.AI in terms of sensitivity and specificity with respect to a ground truth, as established by trained thoracic radiologists, in the detection of penumonia. In addition, the study will compare time to notification for the InferRead CT Pneumonia.AI software with respect to the time to notification for the standard of care as established from available radiological reports. 1. To evaluate the performance of InferRead CT Pneumonia.AI. 2. To evaluate the effect of different factors such as CT manufacturer, CT scanning protocols and patient characteristics on the performance of InferRead CT Pneumonia.AI

Conditions

• Pneumonia

Interventions

Type	Name	Description
DEVICE	InferRead CT Pneumonia.AI	InferRead CT Pneumonia.AI reads chest CT DICOM images from medical imaging storage devices and triages cases by detecting pneumonia lesions and then flagging suspected cases in the study list. InferRead CT Pneumonia.AI is a tool to assist clinicians and it does not replace the interpretation and diagnosis by clinicians.

Timeline

• Start date: 2021-09-01
• Primary completion: 2022-01-31
• Completion: 2022-01-31
• First posted: 2021-07-09
• Last updated: 2021-07-09

Regulatory

• FDA-regulated device study