A Retrospective, Multicenter, Controlled Clinical Trail: to Evaluate the Efficiency and Safety of Intracranial Aneurysm Assistive Software in the Preoperative Assessment

NCT ID: NCT05651425

Last Updated: 2022-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-20

Study Completion Date

2023-04-30

Brief Summary

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the goal of this clinical trail is to evaluate the efficiency and safety of intracranial aneurysm assistive software in the preoperative assessment. 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 efficiency and safety of intracranial aneurysm assistive software is evaluated reliably and precisely. In our trail, software-assisstant planning controls against experienced-surgeon-independent planning,which aims to avoid bias effictively and eliminate non-test interferences.

Detailed Description

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Conditions

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Intracranial Aneurysm

Keywords

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intracranial aneurysm intravascular coiling embolization

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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surgeon-independent group

the coiling diameter is predicted by experienced surgeon alone.

No interventions assigned to this group

surgeon-software-assistant group

the coiling diameter is predicted by experienced surgeon with software assistant.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. aged 18-80y, no gender limitation.
2. non-ruptured intracranial saccular aneurysm with specific intracranial CTA images; Target aneurysm has performed intravascular coiling treatment.
3. intracranial aneurysm diameter range from 3mm to 10mm.
4. the shape of aneurysm is regular without daughter sac or more than 2 lobulations.


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. significant proximal stenosis of parent artery;
5. intracaverous internal carotid artery aneurysm;
6. target aneurysm has been performed flow-diverter stents treatment.


1. none DICOM format;
2. quality score less than 3 scores;
3. metal artifacts existance.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role collaborator

Shanxi Provincial People's Hospital

OTHER_GOV

Sponsor Role collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wang Shuo

Director of Department of Cerebrovascular Neurosurgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shuo Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Locations

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Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shuo Wang, MD

Role: CONTACT

Phone: 13801180330

Email: [email protected]

Qinyuan Liu, MD

Role: CONTACT

Phone: 13260457220

Email: [email protected]

Facility Contacts

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Qingyuan Liu, MD

Role: primary

Other Identifiers

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QX2022-011-02

Identifier Type: -

Identifier Source: org_study_id