Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02977520
Recruitment Status : Unknown
Verified November 2016 by Beijing Luhe Hospital.
Recruitment status was:  Recruiting
First Posted : November 30, 2016
Last Update Posted : November 30, 2016
Sponsor:
Information provided by (Responsible Party):
Beijing Luhe Hospital

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.

Condition or disease Intervention/treatment Phase
Printing, Three-Dimensional, Simulation Training Procedure: Printing, Three-Dimensional Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preoperative Assessment and Individualized Operation Optimization of Acute Ruptured Cerebral Aneurysms
Study Start Date : November 2016
Estimated Primary Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Arm Intervention/treatment
Experimental: Interventional group
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.
Procedure: Printing, Three-Dimensional
To establish 3D model of cerebral aneurysms and have preoperative evaluation.

No Intervention: general group
Obtain the CTA data of cerebral aneurysms, the neurosurgeon complete the discussion of preoperative prediction of aneurysms.



Primary Outcome Measures :
  1. time of operation [ Time Frame: 1 to 3 hours ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02977520


Contacts
Layout table for location contacts
Contact: QING HUANG, M.D. 86-10-69543901 ext 2053 huangqing@ccmu.edu.cn
Contact: YANLONG HU, M.D. 86-10-69543901 ext 2055 doctor_yanlonghu@hotmail.com

Locations
Layout table for location information
China, Beijing
Beijing Luhe hospital Recruiting
Beijing, Beijing, China, 101149
Contact: QING HUANG, M.D.    86-10-69543901 ext 2053    huangqing@ccmu.edu.cn   
Principal Investigator: QING HUANG, M.D.         
Sponsors and Collaborators
Beijing Luhe Hospital

Layout table for additonal information
Responsible Party: Beijing Luhe Hospital
ClinicalTrials.gov Identifier: NCT02977520     History of Changes
Other Study ID Numbers: TWKY-2016-ZD-01-10
First Posted: November 30, 2016    Key Record Dates
Last Update Posted: November 30, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Layout table for MeSH terms
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases