Tetralogy of FallotNCT00155428
Biomodel in Tetralogy of Fallot
A study testing rapid prototyping and computed tomography in people with Tetralogy of Fallot, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Using biocardiac model in helping the total correction of the Tetralogy of Fallot. Read more about this study
- Who is it for?
- Ages 1 month to 20 years
- Conditions the study is for
- Tetralogy of Fallot
- What is being tested?
- rapid prototyping and computed tomography
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2005to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Tetralogy of Fallot
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Dept. Medical Imaging, NTUH
Taipei, 100
Shyh-Jye Chen, MD, PhD, +886-23565586, james@ntumc.org
Shyh-Jye Chen, MD, PhD
About this study
Official title: Application of Biocardiac Model in Total Correction of Tetralogy of Fallot
Using biocardiac model in helping the total correction of the Tetralogy of Fallot.
Read the detailed description
Using biocardiac model in helping the total correction of the Tetralogy of Fallot.
- Conditions
- Tetralogy of Fallot
- Being tested
- rapid prototyping, computed tomography
- Keywords
- biomodel, rapid prototyping, computed tomograpgy
- Medical subject headings
- Tetralogy of Fallot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rapid prototypingProcedure or surgery
computed tomographyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic accuracy
Secondary outcomes (2)
sensitivity
specificity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startMay 2005
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tetralogy of FallotStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Shyh-Jye Chen, MD, PhD, Principal investigator, Dept. Medical Imaging, NTUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00155428
- Sponsor's protocol ID
- 9461700518
- Status last verified
- May 2005
- First submitted
- 8 Sep 2005
- Last updated
- 20 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Biocardiac Model in Total Correction of Tetralogy of Fallot
- ClinicalTrials.gov ID
- NCT00155428
- Acronym / sponsor ID
- 9461700518
- Conditions
- Tetralogy of Fallot
- Keywords
- biomodel, rapid prototyping, computed tomograpgy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- May 2005
- Study completion
- Dec 2008
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 1 month to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Tetralogy of Fallot
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rapid prototyping | Procedure or surgery | – |
| computed tomography | Procedure or surgery | – |
Primary outcome
diagnostic accuracy
2 secondary outcomes
sensitivity
specificity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shyh-Jye Chen, MD, PhD principal investigator
Dept. Medical Imaging, NTUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rapid prototyping and computed tomography in people with Tetralogy of Fallot, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic accuracy. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2005.