Printing, Three-Dimensional, Simulation TrainingPAOCANCT02977520
Preoperative Assessment and Individualized Operation Optimization of Acute Ruptured Cerebral Aneurysms
A study testing Printing, Three-Dimensional in people with Printing, Three-Dimensional, Simulation Training, run by Beijing Luhe Hospital at 1 site in China.
Trial summary
Cerebral aneurysm is one of the main diseases that seriously affect human health. The most important treatment method is surgical clipping and endovascular embolization. Not complete occlusion of the aneurysm is a main risk of recurrence and rebleeding after treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Printing, Three-Dimensional, Simulation Training
- What is being tested?
- Printing, Three-Dimensional
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to May 2017
- Phase
- Interventional
- 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
Who may be able to join
- Age: 18 years-80 years;
- Hunt-Hess grade: 0-4;
- Without other stroke, brain trauma and other neurological disease;
- Without cerebral hernia;
- Cystic aneurysm.
Who cannot join
- Age: less than 18 years or above 80 years;
- Hunt-Hess grade is 5;
- With serious previous disorder of multiple organ;
- Acute cerebral hernia;
- Aneurysms were fusiform or serpentine expansion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Luhe hospital
Beijing, Beijing Municipality, 101149
QING HUANG, M.D., 86-10-69543901 ext. 2053, huangqing@ccmu.edu.cn
QING HUANG, M.D.
About this study
Cerebral aneurysm is one of the main diseases that seriously affect human health. The most important treatment method is surgical clipping and endovascular embolization. Not complete occlusion of the aneurysm is a main risk of recurrence and rebleeding after treatment. This study is focused on the 3D model of cerebral aneurysms and preoperative evaluation. Combined with the 3D model, the neurosurgeon can complete the discussion of preoperative prediction of aneurysms and recognize the adjacent bone, blood vessels, aneurysm directions and so on. In addition, the model can also be used to the young doctor's training, and the patient and their families can be convenient and intuitive understanding of the disease, so as to form a good communication between doctors and patients.
- Being tested
- Printing, Three-Dimensional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Printing, Three-DimensionalProcedure or surgery
To establish 3D model of cerebral aneurysms and have preoperative evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | Obtain the CTA data of cerebral aneurysms and built the 3D printing models. Combined with the 3D model, the neurosurgeon can complete the discussion of preoperative prediction of aneurysms and recognize the adjacent bone, blood vessels, aneurysm directions and so on. In addition, the model can also be used to the young doctor's training, and the patient and their families can be convenient and intuitive understanding of the disease, so as to form a good communication between doctors and patients. Receives: Procedure: Printing, Three-Dimensional |
| general group | No intervention | Obtain the CTA data of cerebral aneurysms, the neurosurgeon complete the discussion of preoperative prediction of aneurysms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
time of operation
Measured: 1 to 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Printing, Three-Dimensional, Simulation TrainingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Luhe Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02977520
- Sponsor's protocol ID
- TWKY-2016-ZD-01-10
- Acronym
- PAOCA
- Status last verified
- Nov 2016
- First submitted
- 28 Nov 2016
- Last updated
- 30 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Assessment and Individualized Operation Optimization of Acute Ruptured Cerebral Aneurysms
- ClinicalTrials.gov ID
- NCT02977520
- Acronym / sponsor ID
- PAOCA / TWKY-2016-ZD-01-10
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Beijing Luhe HospitalUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- May 2017 (estimated)
- First posted
- 30 Nov 2016 (estimated)
- 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.
Cerebral aneurysm is one of the main diseases that seriously affect human health. The most important treatment method is surgical clipping and endovascular embolization. Not complete occlusion of the aneurysm is a main risk of recurrence and rebleeding after treatment. This study is focused on the 3D model of cerebral aneurysms and preoperative evaluation. Combined with the 3D model, the neurosurgeon can complete the discussion of preoperative prediction of aneurysms and recognize the adjacent bone, blood vessels, aneurysm directions and so on. In addition, the model can also be used to the young doctor's training, and the patient and their families can be convenient and intuitive understanding of the disease, so as to form a good communication between doctors and patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Procedure: Printing, Three-DimensionalObtain the CTA data of cerebral aneurysms and built the 3D printing models. Combined with the 3D model, the neurosurgeon can complete the discussion of preoperative prediction of aneurysms and recognize the adjacent bone, blood vessels, aneurysm directions and so on. In addition, the model can also be used to the young doctor's training, and the patient and their families can be convenient and intuitive understanding of the disease, so as to form a good communication between doctors and patients. |
| general group | No intervention | –Obtain the CTA data of cerebral aneurysms, the neurosurgeon complete the discussion of preoperative prediction of aneurysms. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 18 years-80 years;
- Hunt-Hess grade: 0-4;
- Without other stroke, brain trauma and other neurological disease;
- Without cerebral hernia;
- Cystic aneurysm.
Key exclusion criteria (5 listed)
- Age: less than 18 years or above 80 years;
- Hunt-Hess grade is 5;
- With serious previous disorder of multiple organ;
- Acute cerebral hernia;
- Aneurysms were fusiform or serpentine expansion.
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 |
|---|---|---|
| Printing, Three-DimensionalTo establish 3D model of cerebral aneurysms and have preoperative evaluation. | Procedure or surgery | Interventional group |
Primary outcome
time of operation
Time frame: 1 to 3 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2016.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Printing, Three-Dimensional in people with Printing, Three-Dimensional, Simulation Training, run by Beijing Luhe 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 5 inclusion and 5 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 30 Nov 2016. 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 QING HUANG, M.D. (86-10-69543901 ext. 2053, huangqing@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time of operation (time frame: 1 to 3 hours). 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 30 Nov 2016.