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Retrospective, multi-center, multi-reader, multi-case(MRMC) clinical trial to evaluate the effectiveness and safety of CTA image assisted brain and carotid aneurysm detection software

Clinical trials of CTA image assisted brain and carotid aneurysm detection software

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300071157
Enrollment
Unknown
Registered
2023-05-06
Start date
2023-05-05
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

Brain and carotid aneurysm

Interventions

Gold Standard:The reference standard will be established by two senior doctors who will review all included brain and neck CTA image cases in a blinded and independent manner. They will mark the aneur
Index test:Doctors read CTA image in AI software assisted conditions

Sponsors

Affiliated Hospital of Hebei University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patient aged =18 years old; 2. Patient underwent brain and carotid CTA examination and has complete CTA image (scanning range from aortic arch to cranial vault) and report; 3. Image layer thickness =1mm.

Exclusion criteria

Exclusion criteria: 1. Poor image quality, such as high image noise or misalignment; 2. Severe motion artifacts or metal artifacts(caused by stents, steel nails, dentures, etc); 3. Patient with a history of neck arterial bypass surgery, cerebrovascular surgery (such as stent placement, embolization, clipping of aneurysms, etc.), moyamoya disease, or brain tumors; 4. Patient with severe variations, deformities, arteriovenous fistulas, or extreme tortuosity of the neck artery and vein; 5. Patient deemed unsuitable for inclusion by the researchers.

Design outcomes

Primary

MeasureTime frame
Sensitivity;Specificity;AFROC-AUC;

Countries

China

Contacts

Public ContactXiaoping Yin

Affiliated Hospital of Hebei University

yinxiaoping78@sina.com+86 13103128133

Outcome results

None listed

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