A Retrospective, Multicenter, Controlled Clinical Trail: to Evaluate the Clinical Efficiency of Intracranial Aneurysm Assistive Software in the Morphological Measurement
1 other identifier
observational
1,500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 25, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 25, 2023
CompletedFirst Submitted
Initial submission to the registry
March 27, 2023
CompletedFirst Posted
Study publicly available on registry
April 7, 2023
CompletedApril 7, 2023
March 1, 2023
2.2 years
March 27, 2023
March 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intracranial aneurysm size
10 years
Secondary Outcomes (7)
Intracranial aneurysm volume
10 years
Intracranial aneurysm height
10 years
Intracranial aneurysm neck diameter
10 years
Parent artery diameter
10 years
Intracranial aneurysm width
10 years
- +2 more secondary outcomes
Study Arms (2)
Intracranial Aneurysms
Normal Vessels
Interventions
Eligibility Criteria
Chinese
You may qualify if:
- aged 18-75y, no gender limitation.
- non-ruptured intracranial saccular aneurysm with specific intracranial CTA images.
- Intracranial aneurysm was not treated.
- the number of detector rows of Computed Tomography(CT) is more than 16 rows.
- slice thickness ≤ 0.625mm, whole-brain image is considered.
- Both plain scan sequences and enhancer sequence are required.
You may not qualify if:
- combined with cerebral hemorrhage;
- combined with cerevascular malformation or cerebral occupying lesion;
- fusiform aneurysm or dissection aneurysm;
- intracaverous internal carotid artery aneurysm;
- none DICOM format;
- quality score less than 3 scores;
- metal artifacts existance.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beijing Tiantan Hospitallead
- Wuxi No. 2 People's Hospitalcollaborator
- RenJi Hospitalcollaborator
- Shanxi Provincial People's Hospitalcollaborator
- Beijing Chao Yang Hospitalcollaborator
- Beijing Friendship Hospitalcollaborator
- Guangzhou Red Cross Hospitalcollaborator
Study Sites (1)
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of neurosurgery
Study Record Dates
First Submitted
March 27, 2023
First Posted
April 7, 2023
Study Start
January 1, 2021
Primary Completion
March 25, 2023
Study Completion
March 25, 2023
Last Updated
April 7, 2023
Record last verified: 2023-03