- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05804474
A Retrospective, Multicenter, Controlled Clinical Trail: to Evaluate the Clinical Efficiency of Intracranial Aneurysm Assistive Software in the Morphological Measurement
March 27, 2023 updated by: Wang Shuo, Beijing Tiantan Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
1500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China
- Beijing TianTan Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Chinese
Description
Inclusion Criteria:
- aged 18-75y, no gender limitation.
- non-ruptured intracranial saccular aneurysm with specific intracranial CTA images.
- Intracranial aneurysm was not treated.
Inclusion criteria of images:
- 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.
Exclusion Criteria:
- combined with cerebral hemorrhage;
- combined with cerevascular malformation or cerebral occupying lesion;
- fusiform aneurysm or dissection aneurysm;
- intracaverous internal carotid artery aneurysm;
Exclusion criteria of images:
- none DICOM format;
- quality score less than 3 scores;
- metal artifacts existance.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Intracranial Aneurysms
|
Observational study
|
Normal Vessels
|
Observational study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Intracranial aneurysm size
Time Frame: 10 years
|
10 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Intracranial aneurysm volume
Time Frame: 10 years
|
10 years
|
Intracranial aneurysm height
Time Frame: 10 years
|
10 years
|
Intracranial aneurysm neck diameter
Time Frame: 10 years
|
10 years
|
Parent artery diameter
Time Frame: 10 years
|
10 years
|
Intracranial aneurysm width
Time Frame: 10 years
|
10 years
|
Aspect ratio
Time Frame: 10 years
|
10 years
|
Size ratio
Time Frame: 10 years
|
10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2021
Primary Completion (Actual)
March 25, 2023
Study Completion (Actual)
March 25, 2023
Study Registration Dates
First Submitted
March 27, 2023
First Submitted That Met QC Criteria
March 27, 2023
First Posted (Actual)
April 7, 2023
Study Record Updates
Last Update Posted (Actual)
April 7, 2023
Last Update Submitted That Met QC Criteria
March 27, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- QX2022-011-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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