Preoperative Assessment and Individualized Operation Optimization of Acute Ruptured Cerebral Aneurysms

Printing, Three-Dimensional, Simulation Training Clinical Trial

— PAOCA  

Official title:

Preoperative Assessment and Individualized Operation Optimization of Acute Ruptured Cerebral Aneurysms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02977520
• Other study ID #: TWKY-2016-ZD-01-10
• Status: Recruiting
• Phase: N/A
• First received: November 28, 2016
• Last updated: November 29, 2016
• Start date: November 2016

Study information

• Verified date: November 2016
• Source: Beijing Luhe Hospital
• Contact: QING HUANG, M.D.
• Phone: 86-10-69543901
• Email: huangqing[@]ccmu.edu.cn
• Is FDA regulated: No
• Health authority: Capital Medical University:China
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age: 18 years-80 years;

• Hunt-Hess grade: 0-4;

• Without other stroke, brain trauma and other neurological disease;

• Without cerebral hernia;

• Cystic aneurysm.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Printing, Three-Dimensional, Simulation Training

Intervention

Procedure:
• Printing, Three-Dimensional
To establish 3D model of cerebral aneurysms and have preoperative evaluation.

Locations

Country	Name	City	State
China	Beijing Luhe hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Luhe Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time of operation		1 to 3 hours	Yes