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Assess the Clinical Effectiveness in AI Prioritising CT Heads

NCT06027411 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 16800

Last updated 2024-03-21

No results posted yet for this study

Summary

Non-Contrast Computed Tomography (NCCT) of the head is the most common imaging method used to assess patients attending the Emergency Department (ED) with a wide range of significant neurological presentations including trauma, stroke, seizure and reduced consciousness. Rapid review of the images supports clinical decision-making including treatment and onward referral.

Radiologists, those reporting scans, often have significant backlogs and are unable to prioritise abnormal images of patients with time critical abnormalities. Similarly, identification of normal scans would support patient turnover in ED with significant waits and pressure on resources.

To address this problem, Qure.AI has worked to develop the market approved qER algorithm, which is a software program that can analyse CT head to identify presence of abnormalities supporting workflow prioritisation.

This study will trial the software in 4 NHS hospitals across the UK to evaluate the ability of the software to reduce the turnaround time of reporting scans with abnormalities that need to be prioritised.

Conditions

  • Trauma, Brain
  • Mass Lesion
  • Skull Fractures
  • Hemorrhage, Intracranial
  • Midline Deviation
  • Stroke, Ischemic
  • Encephalomalacia

Interventions

DEVICE

qER (qER EU 2.0)

Qure.ai's emergency room software solution qER (qER EU 2.0) is an AI medical device, developed by training a deep-learning algorithm using over 300,000 scans labelled by expert radiologists. qER has been shown to be accurate in identifying a range of abnormalities in NCCT head scans as well as prioritising them for urgent review and radiologist reporting. It is designated as a clinical support tool and, when used with original scans, can assist the clinician to improve efficiency, accuracy, and turnaround time in reading head CTs.

Sponsors & Collaborators

  • Qure.ai

    collaborator UNKNOWN

  • NHS Greater Glasgow and Clyde

    collaborator OTHER

  • Northumbria Healthcare NHS Foundation Trust

    collaborator OTHER

  • Oxford University Hospitals NHS Trust

    collaborator OTHER

  • Guy's and St Thomas' NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Haris Shuaib, MSc · Guy's and St.Thomas' Hospitals

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-27
Primary Completion
2024-08-31
Completion
2024-08-31
FDA Device
Yes

Countries

  • United Kingdom

Study Locations

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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 NCT06027411 on ClinicalTrials.gov