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A multicenter, self-controlled, paired clinical trial to evaluate the clinical performance of CT image-assisted triage software for intracranial hemorrhage triage

A multicenter, self-controlled, paired clinical trial to evaluate the clinical performance of CT image-assisted triage software for intracranial hemorrhage triage

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200063164
Enrollment
Unknown
Registered
2022-09-01
Start date
2022-09-01
Completion date
Unknown
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperacute and acute stages of intracranial hemorrhage

Interventions

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Sponsors

Zhujiang Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Cranial CT plain scan imaging, CT image thickness =16 rows. 2. The first cranial CT examination is performed after the patient has an emergency cause, including but not limited to: trauma, dizziness, headache, elevated blood pressure, neurological dysfunction, etc. 3. The image report or image performance conforms to any of the following: (1) Report intracranial hemorrhage and imaging report indicates acute/hyperacute phase, or the traceable onset time is less than 72 hours; (2) No intracranial hemorrhage was reported; (3) Imaging and related clinical information are complete and can be traced.

Exclusion criteria

Exclusion criteria: 1. Do not conform to the DICOM standard; 2. With a history of craniocerebral surgery, including but not limited to: craniotomy, coil placement, stent placement, vascular malformation embolization, etc.; 3. Images of enrolled subjects at different periods; 4. The image quality is not qualified, and there are artifacts that obviously affect the overall image quality, such as motion artifacts, metal artifacts, built-in artifacts, hardening artifacts, etc.; 5. The researchers considered that other reasons were not suitable for inclusion, such as the scan scope did not completely cover the whole brain, the image was seriously skewed, or the evaluation could not be carried out due to other reasons.

Design outcomes

Secondary

MeasureTime frame
triage consistency rate;positive predictive value;negative predictive value;Dice coefficient of suspected lesion area;measurement error of suspected lesion volume;device performance evaluation;

Primary

MeasureTime frame
sensitivity;specificity;

Countries

China

Contacts

Public ContactWen Zhibo
zhibowen@163.com+86 18902914951

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026