Multi-Reader Retrospective Study Examining Carebot AI CXR 2.0.21-v2.01 Implementation in Everyday Radiology Clinical Practice

Carebot s.r.o.

Status: Completed

Conditions: Cardiomegaly; Pulmonary Nodule, Solitary; Pneumothorax; Pleural Effusion; Consolidation; Atelectasis; Subcutaneous Emphysema

Treatments: Device: Carebot AI CXR

Study type: Observational

Funder types: Industry

Identifiers

NCT05963945

00002

Details and patient eligibility

About

The primary objective is to evaluate the performance parameters of the proposed DLAD (Carebot AI CXR) in comparison to individual radiologists.

Full description

In the period between October 18th, 2022, and November 17th, 2022, anonymized chest X-ray images of patients were collected at the Radiodiagnostic Department of the Havířov Hospital, p.o. The collection process involved utilizing the CloudPACS imaging and archiving system provided by OR-CZ spol. s r.o.

The collected X-ray images were subjected to the proposed DLAD (Carebot AI CXR) for analysis. Subsequently, the DLAD's performance was compared with the standard clinical practice, where radiologists assessed the CXR images in the simulated hospital setting with access to standard viewing tools (e.g., pan, zoom, WW/WL) and were given an unlimited amount of time to complete the review. Each radiologist determined the presence or absence of 7 indicated radiological findings, including atelectasis (ATE), consolidation (CON), pleural effusion (EFF), pulmonary lesion (LES), subcutaneous emphysema (SCE), cardiomegaly (CMG), and pneumothorax (PNO).

Enrollment: 956 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hospital patients > 18 years who were referred for chest radiography October 18th, 2022, and November 17th, 2022 at the Radiodiagnostic Department of the Havířov Hospital, p.o.

Exclusion criteria

• Patients < 18 years
• Chest X-ray images in lateral positions
• Duplicated chest X-ray images

Trial design

956 participants in 1 patient group

Retrospective collection for the period October 18th, 2022, and November 17th, 2022

Description:

A total of 1,073 chest X-rays were acquired within the specified period at the department. The data collection remained intact and unaffected throughout the testing phase, ensuring the integrity of the dataset. The collected sample accurately represents the prevalence of findings within the observed population. After excluding ineligible studies such as X-rays from patients under 18 years of age, lateral projection X-rays, and scans of insufficient quality, a total of 956 relevant CXRs were identified for further assessment.

Treatment:

Device: Carebot AI CXR