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

November 29, 2016 updated by: Beijing Luhe Hospital
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 101149
        • Recruiting
        • Beijing Luhe hospital
        • Contact:
        • Principal Investigator:
          • QING HUANG, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
time of operation
Time Frame: 1 to 3 hours
1 to 3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Luhe Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

November 28, 2016

First Submitted That Met QC Criteria

November 29, 2016

First Posted (Estimate)

November 30, 2016

Study Record Updates

Last Update Posted (Estimate)

November 30, 2016

Last Update Submitted That Met QC Criteria

November 29, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TWKY-2016-ZD-01-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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