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

• Sponsor: Beijing Tiantan Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05804474
• Collaborator: Wuxi No. 2 People's Hospital (Other), RenJi Hospital (Other), Shanxi Provincial People's Hospital (Other), Beijing Chao Yang Hospital (Other), Beijing Friendship Hospital (Other), Guangzhou Red Cross Hospital (Other)
• Enrollment: 1,500
• Location: 1
• Actual Duration (Months): 26.7
• Patients Per Site Per Month: 56.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intracranial Aneurysm	Other: Observational study

Study Design

• Study Type: Observational
• Actual Enrollment: 1500 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: A Retrospective, Multicenter, Controlled Clinical Trail: to Evaluate the Clinical Efficiency of Intracranial Aneurysm Assistive Software in the Morphological Measurement
• Actual Study Start Date: Jan 1, 2021
• Actual Primary Completion Date: Mar 25, 2023
• Actual Study Completion Date: Mar 25, 2023

Arms and Interventions

Arm	Intervention/Treatment
Intracranial Aneurysms	Other: Observational study; Observational study
Normal Vessels	Other: Observational study; Observational study

Outcome Measures

Primary Outcome Measures

1. Intracranial aneurysm size [10 years]

Secondary Outcome Measures

1. Intracranial aneurysm volume [10 years]

2. Intracranial aneurysm height [10 years]

3. Intracranial aneurysm neck diameter [10 years]

4. Parent artery diameter [10 years]

5. Intracranial aneurysm width [10 years]

6. Aspect ratio [10 years]

7. Size ratio [10 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Tiantan Hospital	Beijing	Beijing	China

Sponsors and Collaborators

• Beijing Tiantan Hospital
• Wuxi No. 2 People's Hospital
• RenJi Hospital
• Shanxi Provincial People's Hospital
• Beijing Chao Yang Hospital
• Beijing Friendship Hospital
• Guangzhou Red Cross Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wang Shuo, Department of neurosurgery, Beijing Tiantan Hospital
• ClinicalTrials.gov Identifier: NCT05804474
• Other Study ID Numbers: QX2022-011-01
• First Posted: Apr 7, 2023
• Last Update Posted: Apr 7, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Wang Shuo, Department of neurosurgery, Beijing Tiantan Hospital: Intracranial Aneurysm; Artificial Intelligence; Morphological measurement
• Additional relevant MeSH terms: Intracranial Aneurysm; Aneurysm

Study Results

No Results Posted as of Apr 7, 2023