Intracranial AneurysmNCT05651425
A Retrospective, Multicenter, Controlled Clinical Trail: to Evaluate the Efficiency and Safety of Intracranial Aneurysm Assistive Software in the Preoperative Assessment
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 efficiency and safety of intracranial aneurysm assistive software in the preoperative assessment. The trail is designed as retrospective, multicenter, controlled clinical trail. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Aneurysm
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2022to 30 Apr 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese
Who may be able to join
- aged 18-80y, no gender limitation.
- non-ruptured intracranial saccular aneurysm with specific intracranial CTA images; Target aneurysm has performed intravascular coiling treatment.
- intracranial aneurysm diameter range from 3mm to 10mm.
- the shape of aneurysm is regular without daughter sac or more than 2 lobulations.
- 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;
- significant proximal stenosis of parent artery;
- intracaverous internal carotid artery aneurysm;
- target aneurysm has been performed flow-diverter stents treatment.
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- none DICOM format;
- quality score less than 3 scores;
- metal artifacts existance.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality
Qingyuan Liu, MD, 13260457220, 13260457220@163.com
About this study
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.
- Conditions
- Intracranial Aneurysm
- Keywords
- intracranial aneurysm, intravascular coiling embolization
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| surgeon-independent group | the coiling diameter is predicted by experienced surgeon alone. | |
| surgeon-software-assistant group | the coiling diameter is predicted by experienced surgeon with software assistant. |
What is being measured
The primary outcome is the main question the study is designed to answer.
concordance rate
the optimal coiling diameter used in surgery is considered as "gold standard". The concordance rate is defined as computational suitable coiling diameter in test group differs gold standard less than ±1mm.
concordance rate=the number of concordance matched/totle enrolled number*100%
Measured: accessment time point : immediately after computational coiling diameter assessment finished.
Secondary outcomes (1)
coincidence rate
the optimal coiling diameter used in surgery is considered as "gold standard". The coincidence rate is defined as computational suitable coiling diameter in test group is less than gold standard.
coincidence rate= the number meets coincidence requirement /totle enrolled *100%
Measured: accessment time point: immediately after computational coiling diameter assessment finished.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start20 Dec 2022 (estimated)
- Primary completion20 Jan 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
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.
- 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-control
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- RenJi Hospital, Shanxi Provincial People's Hospital
- Responsible party
- Principal investigator, Wang Shuo, Beijing Tiantan Hospital
- Investigators
- Shuo Wang, MD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05651425
- Sponsor's protocol ID
- QX2022-011-02
- Status last verified
- Dec 2022
- First submitted
- 23 Nov 2022
- Last updated
- 15 Dec 2022
- 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 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Multicenter, Controlled Clinical Trail: to Evaluate the Efficiency and Safety of Intracranial Aneurysm Assistive Software in the Preoperative Assessment
- ClinicalTrials.gov ID
- NCT05651425
- Acronym / sponsor ID
- QX2022-011-02
- Conditions
- Intracranial Aneurysm
- Keywords
- intracranial aneurysm, intravascular coiling embolization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- RenJi Hospital, Shanxi Provincial People's Hospital
- Study start
- 20 Dec 2022 (estimated)
- Primary completion
- 20 Jan 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 15 Dec 2022 (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 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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgeon-independent group | – | –the coiling diameter is predicted by experienced surgeon alone. |
| surgeon-software-assistant group | – | –the coiling diameter is predicted by experienced surgeon with software assistant. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese
Key inclusion criteria (7 listed)
- aged 18-80y, no gender limitation.
- non-ruptured intracranial saccular aneurysm with specific intracranial CTA images; Target aneurysm has performed intravascular coiling treatment.
- intracranial aneurysm diameter range from 3mm to 10mm.
- the shape of aneurysm is regular without daughter sac or more than 2 lobulations.
- the number of detector rows of Computed Tomography(CT) is more than 16 rows.
Key exclusion criteria (9 listed)
- combined with cerebral hemorrhage;
- combined with cerevascular malformation or cerebral occupying lesion;
- fusiform aneurysm or dissection aneurysm;
- significant proximal stenosis of parent artery;
- intracaverous internal carotid artery aneurysm;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
concordance rate
Time frame: accessment time point : immediately after computational coiling diameter assessment finished.
the optimal coiling diameter used in surgery is considered as "gold standard". The concordance rate is defined as computational suitable coiling diameter in test group differs gold standard less than ±1mm. concordance rate=the number of concordance matched/totle enrolled number*100%
1 secondary outcome
coincidence rate
Time frame: accessment time point: immediately after computational coiling diameter assessment finished.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
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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.
Shuo Wang, MD principal investigator
Beijing Tiantan Hospital
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 7 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 15 Dec 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shuo Wang, MD (13801180330, captain5868@162.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
concordance rate (time frame: accessment time point : immediately after computational coiling diameter assessment finished.). 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 15 Dec 2022.