Blocked Ventricular ShuntsPhase 4NCT00788385
Multi-Center Study of ShuntCheck
A Phase 4 study testing ShuntCheck test in people with Blocked Ventricular Shunts, run by NeuroDx Development.
Trial summary
Multi-Center Study of ShuntCheck Read more about this study
- Who is it for?
- Ages 1 month to 19 years
- Conditions the study is for
- Blocked Ventricular Shunts
- What is being tested?
- ShuntCheck test
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Dec 2010
- Phase
- Phase 4
- 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 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Inclusion Criteria:
Exclusion Criteria:
About this study
Multi-Center Study of ShuntCheck
- Conditions
- Blocked Ventricular Shunts
- Being tested
- ShuntCheck test
- Keywords
- Hydrocephalus, High Pressure, Shunt Blockage
- Medical subject headings
- Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShuntCheck testDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2008 (estimated)
- Study startJun 2009
- Primary completionJun 2010 (estimated)
- Study completionDec 2010 (estimated)
Why it stopped: Insufficient funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blocked Ventricular ShuntsStudies 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 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuroDx Development
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00788385
- Sponsor's protocol ID
- NDX01-22-2001
- Status last verified
- Apr 2015
- First submitted
- 7 Nov 2008
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Study of ShuntCheck
- ClinicalTrials.gov ID
- NCT00788385
- Acronym / sponsor ID
- NDX01-22-2001
- Conditions
- Blocked Ventricular Shunts
- Keywords
- Hydrocephalus, High Pressure, Shunt Blockage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Insufficient funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NeuroDx DevelopmentIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 10 Nov 2008 (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.
Multi-Center Study of ShuntCheck
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 1 month to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| ShuntCheck test | Device | – |
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 14 Apr 2015.
Related trials for Blocked Ventricular Shunts
Recruiting
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ShuntCheck test in people with Blocked Ventricular Shunts, run by NeuroDx Development.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: withdrawn, as of the sponsor's last update on 14 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 14 Apr 2015.