NCT05230563

A Clinical Study of LUNG-CT CAD Decision Support

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: TaiHao Medical Inc. · Industry
• Sex: All
• Age: 20 Years – 89 Years
• Healthy volunteers: Accepted

Summary

This product is a computer-aided detection software designed to assist clinicians in detecting lung nodules in chest computer tomography. This product receives from PACS, radiology information system or directly from computer tomography scanner. After receiving the image, the product performs image analysis and provides a mark of suspected lung nodules. Users can use existing medical image capture and transmission systems or reading software to view these annotations on the workstation. The main purpose of this trial is to verify that when clinicians perform chest CT pulmonary nodule detection, compared to only diagnosis based on chest CT images, whether the "Taihao" lung CT decision support system helps to improve the diagnostic efficiency of clinicians. The secondary purpose is to evaluate that when clinicians perform chest CT pulmonary nodule detection, compared to only diagnosis based on chest CT images, whether the "Taihao" lung CT decision support system helps to improve the sensitivity, specificity, and image interpretation time (Reading Time) of clinicians.

Conditions

• Lung Cancer
• Lung Diseases

Interventions

Type	Name	Description
DEVICE	Ti-LUNG	Participating clinicians will perform two image interpretations on all cases. One period the clinicians only will perform lung nodule detection on chest CT images, and the other period will perform lung nodule detection on chest CT images with the aid of "Taihao" lung CT decision support system. In each interpretation, all lung nodule is marked by each radiologist. This test collects chest computerized tomography cases for computer analysis, and evaluates whether the "TaiHao" lung CT decision support system helps doctors make more accurate diagnoses.

Timeline

• Start date: 2021-08-19
• Primary completion: 2022-05-31
• Completion: 2022-05-31
• First posted: 2022-02-09
• Last updated: 2022-02-09

Locations

1 site across 1 country: Taiwan