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Retrospective Study of Carebot AI CXR Performance in Preclinical Practice

NCT05594485 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 127

Last updated 2023-07-13

No results posted yet for this study

Summary

The purpose of this study is to describe the design, methodology and evaluation of the preclinical test of Carebot AI CXR software, and to provide evidence that the investigated medical device meets user requirements in accordance with its intended use. Carebot AI CXR is defined as a recommendation system (classification "prediction") based on computer-aided detection. The software can be used in a preclinical deployment at a selected site before interpretation (prioritization, display of all results and heatmaps) or after interpretation (verification of findings) of CXR images, and in accordance with the manufacturer's recommendations. Given this, a retrospective study is performed to test the clinical effectiveness on existing CXRs.

Conditions

  • Artificial Intelligence
  • Lung Diseases
  • Pneumothorax
  • Pleural Effusion
  • Cardiomegaly
  • Lung Cancer
  • Pulmonary Edema
  • Consolidation
  • Pneumonia
  • Atelectasis
  • Hilar Calcification
  • Fracture Rib

Interventions

DEVICE

Carebot AI CXR

Carebot AI CXR is a deep learning-based software that assists radiologists in the interpretation of chest radiographs in posterior-anterior (PA) or anterior-posterior (AP) projections. The solution with artificial intelligence automatically detects abnormality based on visual patterns for the following findings: atelectasis, consolidation, cardiomegaly, mediastinal widening, pneumoperitoneum, pneumothorax, pulmonary edema, pulmonary lesion, bone fracture, hilar enlargement, subcutaneous emphysema, and pleural effusion.

Sponsors & Collaborators

  • Carebot s.r.o.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-15
Primary Completion
2022-08-17
Completion
2022-10-20

Countries

  • Czechia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05594485 on ClinicalTrials.gov