NCT00155428

Brief Summary

Using biocardiac model in helping the total correction of the Tetralogy of Fallot.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

December 20, 2005

Status Verified

May 1, 2005

First QC Date

September 8, 2005

Last Update Submit

December 19, 2005

Conditions

Tetralogy of Fallot

Keywords

biomodelrapid prototypingcomputed tomograpgy

Outcome Measures

Primary Outcomes (1)

  • diagnostic accuracy

Secondary Outcomes (2)

  • sensitivity

  • specificity

Interventions

rapid prototypingPROCEDURE
computed tomographyPROCEDURE

Eligibility Criteria

Age1 Month - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Tetralogy of Fallot

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. Medical Imaging, NTUH

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Tetralogy of Fallot

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Shyh-Jye Chen, MD, PhD

    Dept. Medical Imaging, NTUH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

May 1, 2005

Study Completion

December 1, 2008

Last Updated

December 20, 2005

Record last verified: 2005-05

Locations

TW(1)