A Retrospective, Multicenter, Controlled Clinical Trail: to Evaluate the Clinical Efficiency of Intracranial Aneurysm Assistive Software in the Morphological Measurement

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05804474

Enrollment

1500

Registered

2023-04-07

Start date

2021-01-01

Completion date

2023-03-25

Last updated

2023-04-07

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

Conditions

Intracranial Aneurysm

Keywords

Intracranial Aneurysm, Artificial Intelligence, Morphological measurement

Brief summary

the goal of this clinical trail is to evaluate the clinical efficiency of intracranial aneurysm assistive software in the morphological measurement. The trail is designed as retrospective, multicenter, controlled clinical trail. Collecting probable cases images retrospectively according to inclusion criteria and exclusion criteria strictly. Controlling bias strictly, to make sure the measurement of intracranial aneurysm assistive software is evaluated reliably and precisely. In our trail, six physicions were recruited, containing three neuroradiologists, two radiologists and a residents. Software-assistant planning controls against no software-assisant planning，which aims to evaluate the improvement of morphological measurement efficiency of physicians.

Interventions

OTHERObservational study

Observational study

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. aged 18-75y, no gender limitation. 2. non-ruptured intracranial saccular aneurysm with specific intracranial CTA images. 3. Intracranial aneurysm was not treated. Inclusion criteria of images: 1. the number of detector rows of Computed Tomography(CT) is more than 16 rows. 2. slice thickness ≤ 0.625mm, whole-brain image is considered. 3. Both plain scan sequences and enhancer sequence are required.

Exclusion criteria

1. combined with cerebral hemorrhage; 2. combined with cerevascular malformation or cerebral occupying lesion; 3. fusiform aneurysm or dissection aneurysm; 4. intracaverous internal carotid artery aneurysm;

Design outcomes

Primary

Measure	Time frame
Intracranial aneurysm size	10 years

Secondary

Measure	Time frame
Intracranial aneurysm height	10 years
Intracranial aneurysm neck diameter	10 years
Parent artery diameter	10 years
Intracranial aneurysm volume	10 years
Aspect ratio	10 years
Size ratio	10 years
Intracranial aneurysm width	10 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026