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Preoperative Assessment and Individualized Operation Optimization of Acute Ruptured Cerebral Aneurysms (PAOCA)

Primary Purpose

Printing, Three-Dimensional, Simulation Training

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Printing, Three-Dimensional

About this trial

This is an interventional treatment trial for Printing, Three-Dimensional, Simulation Training

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Beijing Luhe hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Interventional group

general group

Arm Description

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.

Obtain the CTA data of cerebral aneurysms, the neurosurgeon complete the discussion of preoperative prediction of aneurysms.

Outcomes

Primary Outcome Measures

time of operation

Secondary Outcome Measures

Full Information

NCT ID

NCT02977520

First Posted

November 28, 2016

Last Updated

November 29, 2016

Sponsor

Beijing Luhe Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02977520

Brief Title

Preoperative Assessment and Individualized Operation Optimization of Acute Ruptured Cerebral Aneurysms

Acronym

PAOCA

Official Title

Preoperative Assessment and Individualized Operation Optimization of Acute Ruptured Cerebral Aneurysms

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Unknown status

Study Start Date

November 2016 (undefined)

Primary Completion Date

May 2017 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Beijing Luhe Hospital

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Printing, Three-Dimensional, Simulation Training

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Interventional group

Arm Type

Experimental

Arm Description

Arm Title

general group

Arm Type

No Intervention

Arm Description

Obtain the CTA data of cerebral aneurysms, the neurosurgeon complete the discussion of preoperative prediction of aneurysms.

Intervention Type

Procedure

Intervention Name(s)

Printing, Three-Dimensional

Intervention Description

To establish 3D model of cerebral aneurysms and have preoperative evaluation.

Primary Outcome Measure Information:

Title

time of operation

Time Frame

1 to 3 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

QING HUANG, M.D.

Phone

86-10-69543901

Ext

2053

huangqing@ccmu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

YANLONG HU, M.D.

Phone

86-10-69543901

Ext

2055

doctor_yanlonghu@hotmail.com

Facility Information:

Facility Name

Beijing Luhe hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

101149

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

QING HUANG, M.D.

Phone

86-10-69543901

Ext

2053

huangqing@ccmu.edu.cn

First Name & Middle Initial & Last Name & Degree

QING HUANG, M.D.

12. IPD Sharing Statement

Learn more about this trial

Preoperative Assessment and Individualized Operation Optimization of Acute Ruptured Cerebral Aneurysms

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