Normal Pressure HydrocephalusPhase 4NCT00793416
ShuntCheck Accuracy in Detecting Shunt Obstruction Normal Pressure Hydrocephalus (NPH) Patients
A Phase 4 study testing Shunt flow detection in people with Normal Pressure Hydrocephalus, run by NeuroDx Development at 1 site in United States.
Trial summary
The purpose of this study is to examine the role of ShuntCheck and MR Imaging in evaluating the presence or absence of Shunt Obstruction in the patients of Hydrocephalus or Idiopathic Intracranial Hypertension (IIH) undergoing radionuclide test for suspected shunt obstruction. Read more about this study
- Who is it for?
- Ages 35 to 90 years
- Conditions the study is for
- Normal Pressure Hydrocephalus
- What is being tested?
- Shunt flow detection
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Aug 2012
- 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 35 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult Patients > 35 years capable and willing to consent for their participation or consent obtained from a legal guardian.
- Patients with an indwelling shunt and clinical assessment strongly suggestive of shunt obstruction
- Patients are candidates for shunt patency procedures in the elective extension
Who cannot join
- Patients <35 years of age
- Patients with symptoms attributable to valve malfunction or shunt infection
- Patients who need urgent shunt replacement and therefore cannot wait for the SHUNTCHECK evaluation of shunt patency.
- Patients with edema or wound of skin overlying the shunt tissue.
- Patients not capable or not willing to consent to participate in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Medical Center
Baltimore, Maryland, 21287
About this study
Official title: Accuracy of ShuntCheck and MRI in Detection of Shunt Obstruction in Patients Receiving Shunt Patency Test
The purpose of this study is to examine the role of ShuntCheck and MR Imaging in evaluating the presence or absence of Shunt Obstruction in the patients of Hydrocephalus or Idiopathic Intracranial Hypertension (IIH) undergoing radionuclide test for suspected shunt obstruction. This is an exploratory study to determine how a non-invasive device can assist in detection of presence of flow in these patients.
Read the detailed description
This study aims to correlate findings of ShuntCheck and MRI with the Radionuclide patency study. Patients will be enrolled if they have Hydrocephalus or IIH, present with symptoms of shunt obstruction and will need to undergo shunt patency test and an MRI along with standard of care radionuclide study. The ShuntCheck study will be conducted in a clinic, doctor's office or in an emergency room by the treating physician or by trained health care professionals.
Also, patients who are found with shunt obstruction as diagnosed by Radionuclide study will undergo shunt revision and the findings of the study will be correlated with operative findings. Post Shunt replacement patients who also receive adjustable valve will be evaluated with shunt Check, before and after adjustment of valves to detect changes in flow as detected by shunt check.
This is an exploratory study to determine how a non-invasive device can assist in detection of presence of flow in these patients.
Approximately 20 subjects will be enrolled in a single site in this proof of concept, physician sponsored study. An approved, commercial device will be available to the site prior to start of the study.
- Conditions
- Normal Pressure Hydrocephalus
- Being tested
- Shunt flow detection
- Keywords
- Normal Pressure Hydrocephalus, Valve Adjustment, Blocked Shunt in NPH patients, Diagnosis of blockage
- Medical subject headings
- Hydrocephalus, Normal Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shunt flow detectionDevice
Shunt flow detection based upon ShuntCheck results compared to radionuclide test results
| Study group | Role | What they receive |
|---|---|---|
| ShuntCheck measure | Experimental | All patients will have ShuntCheck measurements along with radionuclide shunt patency testing. Receives: Device: Shunt flow detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exploratory Evaluation of the Utility of ShuntCheck in detection of ShuntFlow in patients admitted with potential shunt obstruction
Measured: Pre and post shunt revision surgery
Secondary outcomes (1)
To assess any adverse events that arise from conducting ShuntCheck test To assess the cost effectiveness of ShuntCheck screening upon completion of the study
Measured: Pre and post shunt revision surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionAug 2012
- Study completionAug 2012
Why it stopped: Loss of study staffing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Pressure HydrocephalusStudies 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuroDx Development
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Johns Hopkins University
- Responsible party
- Sponsor
- Investigators
- Daniele Rigamonti, MD, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00793416
- Sponsor's protocol ID
- NDX01-22-2003
- Status last verified
- Oct 2013
- First submitted
- 17 Nov 2008
- Last updated
- 29 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of ShuntCheck and MRI in Detection of Shunt Obstruction in Patients Receiving Shunt Patency Test
- ClinicalTrials.gov ID
- NCT00793416
- Acronym / sponsor ID
- NDX01-22-2003
- Conditions
- Normal Pressure Hydrocephalus
- Keywords
- Normal Pressure Hydrocephalus, Valve Adjustment, Blocked Shunt in NPH patients, Diagnosis of blockage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Loss of study staffing
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NeuroDx DevelopmentIndustry (pharma, biotech, devices)
- Collaborators
- Johns Hopkins University
- Study start
- Nov 2008
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 19 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.
The purpose of this study is to examine the role of ShuntCheck and MR Imaging in evaluating the presence or absence of Shunt Obstruction in the patients of Hydrocephalus or Idiopathic Intracranial Hypertension (IIH) undergoing radionuclide test for suspected shunt obstruction. This is an exploratory study to determine how a non-invasive device can assist in detection of presence of flow in these patients.
Detailed description
This study aims to correlate findings of ShuntCheck and MRI with the Radionuclide patency study. Patients will be enrolled if they have Hydrocephalus or IIH, present with symptoms of shunt obstruction and will need to undergo shunt patency test and an MRI along with standard of care radionuclide study. The ShuntCheck study will be conducted in a clinic, doctor's office or in an emergency room by the treating physician or by trained health care professionals.
Also, patients who are found with shunt obstruction as diagnosed by Radionuclide study will undergo shunt revision and the findings of the study will be correlated with operative findings. Post Shunt replacement patients who also receive adjustable valve will be evaluated with shunt Check, before and after adjustment of valves to detect changes in flow as detected by shunt check.
This is an exploratory study to determine how a non-invasive device can assist in detection of presence of flow in these patients.
Approximately 20 subjects will be enrolled in a single site in this proof of concept, physician sponsored study. An approved, commercial device will be available to the site prior to start of the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ShuntCheck measure | Experimental | Device: Shunt flow detectionAll patients will have ShuntCheck measurements along with radionuclide shunt patency testing. |
Who may qualify
- Ages
- 35 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult Patients > 35 years capable and willing to consent for their participation or consent obtained from a legal guardian.
- Patients with an indwelling shunt and clinical assessment strongly suggestive of shunt obstruction
- Patients are candidates for shunt patency procedures in the elective extension
Key exclusion criteria (5 listed)
- Patients <35 years of age
- Patients with symptoms attributable to valve malfunction or shunt infection
- Patients who need urgent shunt replacement and therefore cannot wait for the SHUNTCHECK evaluation of shunt patency.
- Patients with edema or wound of skin overlying the shunt tissue.
- Patients not capable or not willing to consent to participate in the study
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 |
|---|---|---|
| Shunt flow detectionShunt flow detection based upon ShuntCheck results compared to radionuclide test results | Device | ShuntCheck measure |
Primary outcome
Exploratory Evaluation of the Utility of ShuntCheck in detection of ShuntFlow in patients admitted with potential shunt obstruction
Time frame: Pre and post shunt revision surgery
1 secondary outcome
To assess any adverse events that arise from conducting ShuntCheck test To assess the cost effectiveness of ShuntCheck screening upon completion of the study
Time frame: Pre and post shunt revision surgery
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 29 Oct 2013.
Related trials for Normal Pressure Hydrocephalus
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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.
Daniele Rigamonti, MD principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Shunt flow detection in people with Normal Pressure Hydrocephalus, 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: withdrawn, as of the sponsor's last update on 29 Oct 2013. 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.
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.
What does the primary outcome measure?
Exploratory Evaluation of the Utility of ShuntCheck in detection of ShuntFlow in patients admitted with potential shunt obstruction (time frame: Pre and post shunt revision surgery). 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 29 Oct 2013.