Intracranial AneurysmNCT05804474
A Retrospective, Multicenter, Controlled Clinical Trail: to Evaluate the Clinical Efficiency of Intracranial Aneurysm Assistive Software in the Morphological Measurement
An observational study of Intracranial Aneurysm, run by Beijing Tiantan Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- Observational study
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 25 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Intracranial Aneurysm
- Being tested
- Observational study
- Keywords
- Intracranial Aneurysm, Artificial Intelligence, Morphological measurement
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
Observational study
| Study group | Role | What they receive |
|---|---|---|
| Intracranial Aneurysms | Not described Receives: Other: Observational study | |
| Normal Vessels | Not described Receives: Other: Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial aneurysm size
Measured: 10 years
Secondary outcomes (7)
Intracranial aneurysm volume
Measured: 10 years
Intracranial aneurysm height
Measured: 10 years
Intracranial aneurysm neck diameter
Measured: 10 years
Parent artery diameter
Measured: 10 years
Intracranial aneurysm width
Measured: 10 years
Aspect ratio
Measured: 10 years
Size ratio
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start1 Jan 2021
- Primary completion25 Mar 2023
- Study completion25 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Wuxi No. 2 People's Hospital, RenJi Hospital, Shanxi Provincial People's Hospital, Beijing Chao Yang Hospital, Beijing Friendship Hospital, Guangzhou Red Cross Hospital
- Responsible party
- Principal investigator, Wang Shuo, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05804474
- Sponsor's protocol ID
- QX2022-011-01
- Status last verified
- Mar 2023
- First submitted
- 27 Mar 2023
- Last updated
- 7 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Multicenter, Controlled Clinical Trail: to Evaluate the Clinical Efficiency of Intracranial Aneurysm Assistive Software in the Morphological Measurement
- ClinicalTrials.gov ID
- NCT05804474
- Acronym / sponsor ID
- QX2022-011-01
- Conditions
- Intracranial Aneurysm
- Keywords
- Intracranial Aneurysm, Artificial Intelligence, Morphological measurement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Wuxi No. 2 People's Hospital, RenJi Hospital, Shanxi Provincial People's Hospital, Beijing Chao Yang Hospital, Beijing Friendship Hospital, Guangzhou Red Cross Hospital
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 25 Mar 2023 (actual)
- Study completion
- 25 Mar 2023 (actual)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intracranial Aneurysms | – | Other: Observational study |
| Normal Vessels | – | Other: Observational study |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational studyObservational study | Other | Intracranial Aneurysms, Normal Vessels |
Primary outcome
Intracranial aneurysm size
Time frame: 10 years
7 secondary outcomes
Intracranial aneurysm volume
Time frame: 10 years
Intracranial aneurysm height
Time frame: 10 years
Intracranial aneurysm neck diameter
Time frame: 10 years
Parent artery diameter
Time frame: 10 years
Intracranial aneurysm width
Time frame: 10 years
Aspect ratio
Time frame: 10 years
Size ratio
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysm, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracranial aneurysm size (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.