NA-Study WithdrawnNCT00411658
Devitalized Non-valved Pulmonary Artery Allograft Implant for the Repair of Congenital Cardiac Abnormalities
A study testing Investigational Device, Experimental and Cryopreserved in people with NA-Study Withdrawn, run by LifeNet Health.
Trial summary
Study no longer required Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- NA-Study Withdrawn
- What is being tested?
- Investigational Device, Experimental and Cryopreserved
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 Any age
- Child, Adult, Older adult
About this study
Study no longer required
- Conditions
- NA-Study Withdrawn
- Being tested
- Investigational Device, Experimental, Cryopreserved
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational DeviceDevice
ExperimentalDevice
CryopreservedOther
| Study group | Role | What they receive |
|---|---|---|
| Investigational Device | Experimental | Not described Receives: Device: Investigational Device; Device: Experimental |
| Cryopreserved | Active comparator | Not described Receives: Other: Cryopreserved |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2006 (estimated)
Why it stopped: Submission converted to 510(k)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NA-Study WithdrawnStudies of the same condition, open and under way.
- 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
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- LifeNet Health
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00411658
- Sponsor's protocol ID
- CR06-002
- Status last verified
- Apr 2015
- First submitted
- 13 Dec 2006
- Last updated
- 7 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Devitalized Non-valved Pulmonary Artery Allograft Implant for the Repair of Congenital Cardiac Abnormalities
- ClinicalTrials.gov ID
- NCT00411658
- Acronym / sponsor ID
- CR06-002
- Conditions
- NA-Study Withdrawn
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Submission converted to 510(k)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- LifeNet HealthIndustry (pharma, biotech, devices)
- First posted
- 14 Dec 2006 (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.
Study no longer required
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational Device | Experimental | Device: Investigational Device, Device: Experimental |
| Cryopreserved | Active comparator | Other: Cryopreserved |
Who may qualify
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Investigational Device | Device | Investigational Device |
| Experimental | Device | Investigational Device |
| Cryopreserved | Other | Cryopreserved |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational Device, Experimental and Cryopreserved in people with NA-Study Withdrawn, run by LifeNet Health.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 7 Apr 2015.