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

Intracranial Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05804474
• Other study ID #: QX2022-011-01
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: March 25, 2023

Study information

• Verified date: March 2023
• Source: Beijing Tiantan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: March 25, 2023
• Est. primary completion date: March 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Exclusion criteria of images:

1. none DICOM format;

2. quality score less than 3 scores;

3. metal artifacts existance.

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

Other:
• Observational study
Observational study

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing	Beijing

Sponsors (7)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital	Beijing Chao Yang Hospital, Beijing Friendship Hospital, Guangzhou Red Cross Hospital, RenJi Hospital, Shanxi Provincial People's Hospital, Wuxi No. 2 People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intracranial aneurysm size		10 years
Secondary	Intracranial aneurysm volume		10 years
Secondary	Intracranial aneurysm height		10 years
Secondary	Intracranial aneurysm neck diameter		10 years
Secondary	Parent artery diameter		10 years
Secondary	Intracranial aneurysm width		10 years
Secondary	Aspect ratio		10 years
Secondary	Size ratio		10 years