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Biomodel in Tetralogy of Fallot

Primary Purpose

Tetralogy of Fallot

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
rapid prototyping
computed tomography
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Tetralogy of Fallot focused on measuring biomodel, rapid prototyping, computed tomograpgy

Eligibility Criteria

1 Month - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Tetralogy of Fallot

Sites / Locations

  • Dept. Medical Imaging, NTUHRecruiting

Outcomes

Primary Outcome Measures

diagnostic accuracy

Secondary Outcome Measures

sensitivity
specificity

Full Information

First Posted
September 8, 2005
Last Updated
December 19, 2005
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00155428
Brief Title
Biomodel in Tetralogy of Fallot
Official Title
Application of Biocardiac Model in Total Correction of Tetralogy of Fallot
Study Type
Interventional

2. Study Status

Record Verification Date
May 2005
Overall Recruitment Status
Unknown status
Study Start Date
May 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Taiwan University Hospital

4. Oversight

5. Study Description

Brief Summary
Using biocardiac model in helping the total correction of the Tetralogy of Fallot.
Detailed Description
Using biocardiac model in helping the total correction of the Tetralogy of Fallot.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tetralogy of Fallot
Keywords
biomodel, rapid prototyping, computed tomograpgy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
rapid prototyping
Intervention Type
Procedure
Intervention Name(s)
computed tomography
Primary Outcome Measure Information:
Title
diagnostic accuracy
Secondary Outcome Measure Information:
Title
sensitivity
Title
specificity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Tetralogy of Fallot
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shyh-Jye Chen, MD, PhD
Organizational Affiliation
Dept. Medical Imaging, NTUH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. Medical Imaging, NTUH
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shyh-Jye Chen, MD, PhD
Phone
+886-23565586
Email
james@ntumc.org
First Name & Middle Initial & Last Name & Degree
Shyh-Jye Chen, MD, PhD

12. IPD Sharing Statement

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Biomodel in Tetralogy of Fallot

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