CSF Flow Through the Shunt of a Hydrocephalus PatientNCT00583336
Physician Preference Study of ShuntCheck - Madsen
A study testing ShuntCheck in people with CSF Flow Through the Shunt of a Hydrocephalus Patient, run by NeuroDx Development at 1 site in United States.
Trial summary
ShuntCheck can be used to detect CSF flow in asymptomatic hydrocephalus patients and can be used to detect no-flow in symptomatic patients with shunt obstruction. Secondarily, the ShuntCheck test will yield the clearest results when patients are tested sitting up (or alternatively while supine) Read more about this study
- Who is it for?
- Ages Up to 85 years
- Conditions the study is for
- CSF Flow Through the Shunt of a Hydrocephalus Patient
- What is being tested?
- ShuntCheck
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Sep 2015
- 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 Up to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects must be 0 - 85 years of age, of any race or sex with parent consent for minors
- Subjects must have a chronically indwelling ventriculo-peritoneal shunt that is palpable along the clavicle.
- Subjects must be physically stable as determined by the physician.
Who cannot join
- Subjects with the presence of an open wound at the shunt site that could interfere with the collection of ShuntCheck data.
- Subjects unable to lie supine with head elevated 30 degrees or less
- Subjects who have had shunt surgery within two weeks.
- Inability or unwillingness of subject to endure the test.
- Other judgments of the investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital Boston
Boston, Massachusetts, 02215
Joseph R Madsen, MD
About this study
Official title: Physician Preference Study of the Utility of ShuntCheck to Detect Cerebrospinal Fluid (CSF) in Patients With Ventriculo-Peritoneal CSF Shunts
ShuntCheck can be used to detect CSF flow in asymptomatic hydrocephalus patients and can be used to detect no-flow in symptomatic patients with shunt obstruction.
Secondarily, the ShuntCheck test will yield the clearest results when patients are tested sitting up (or alternatively while supine)
- Being tested
- ShuntCheck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShuntCheckDevice
Thermal dilution test for CSF flow
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic | Experimental | Not described Receives: Device: ShuntCheck |
What is being measured
The primary outcome is the main question the study is designed to answer.
ShuntCheck result of "Flow Confirmed" for asymptomatic shunted patients tested
Measured: Tested in single visit
Secondary outcomes (1)
ShuntCheck result of "Flow Not Confirmed" for symptomatic shunted patients with shunt obstruction
Measured: Single visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2007 (estimated)
- Study startSep 2007
- Primary completionJul 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CSF Flow Through the Shunt of a Hydrocephalus PatientStudies 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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NeuroDx Development
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boston Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Joseph R Madsen, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00583336
- Sponsor's protocol ID
- NDX 07-07-0277
- Other IDs
- 07-07-0277
- Status last verified
- Jun 2015
- First submitted
- 20 Dec 2007
- Last updated
- 23 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physician Preference Study of the Utility of ShuntCheck to Detect Cerebrospinal Fluid (CSF) in Patients With Ventriculo-Peritoneal CSF Shunts
- ClinicalTrials.gov ID
- NCT00583336
- Acronym / sponsor ID
- NDX 07-07-0277
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- NeuroDx DevelopmentIndustry (pharma, biotech, devices)
- Collaborators
- Boston Children's Hospital
- Study start
- Sep 2007
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 31 Dec 2007 (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.
ShuntCheck can be used to detect CSF flow in asymptomatic hydrocephalus patients and can be used to detect no-flow in symptomatic patients with shunt obstruction.
Secondarily, the ShuntCheck test will yield the clearest results when patients are tested sitting up (or alternatively while supine)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic | Experimental | Device: ShuntCheck |
Who may qualify
- Ages
- Up to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects must be 0 - 85 years of age, of any race or sex with parent consent for minors
- Subjects must have a chronically indwelling ventriculo-peritoneal shunt that is palpable along the clavicle.
- Subjects must be physically stable as determined by the physician.
Key exclusion criteria (5 listed)
- Subjects with the presence of an open wound at the shunt site that could interfere with the collection of ShuntCheck data.
- Subjects unable to lie supine with head elevated 30 degrees or less
- Subjects who have had shunt surgery within two weeks.
- Inability or unwillingness of subject to endure the test.
- Other judgments of the investigator.
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 |
|---|---|---|
| ShuntCheckThermal dilution test for CSF flow | Device | Diagnostic |
Primary outcome
ShuntCheck result of "Flow Confirmed" for asymptomatic shunted patients tested
Time frame: Tested in single visit
1 secondary outcome
ShuntCheck result of "Flow Not Confirmed" for symptomatic shunted patients with shunt obstruction
Time frame: Single visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 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.
Joseph R Madsen, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ShuntCheck in people with CSF Flow Through the Shunt of a Hydrocephalus Patient, run by NeuroDx Development at 1 site in United States.
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 3 inclusion and 5 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 23 Jun 2015. 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 United States. 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?
Contact Joseph R Madsen, MD ((617) 355-6005, Joseph.Madsen@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ShuntCheck result of "Flow Confirmed" for asymptomatic shunted patients tested (time frame: Tested in single visit). 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 23 Jun 2015.