Suspected CSF Shunt ObstructionPhase 4NCT01881711
ShuntCheck-Micro-Pumper Pediatric Clinical Outcomes Study
A Phase 4 study testing ShuntCheck-Micro-Pumper (SCMP) and Imaging in people with Suspected CSF Shunt Obstruction, run by NeuroDx Development at 11 sites in United States.
Trial summary
Primary objective is to demonstrate that data collected from ShuntCheck-Micro-Pumper (SCMP) testing results can be used in conjunction with imaging to diagnose shunt patency or obstruction in pediatric/adolescent subjects presenting to an Emergency Department or Neurosurgery Clinic (ED/NC). Read more about this study
- Who is it for?
- Ages 35 months to 29 years
- Conditions the study is for
- Suspected CSF Shunt Obstruction
- What is being tested?
- ShuntCheck-Micro-Pumper (SCMP) and Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 11 sitesUnited States
- Study dates
- May 2013to Sep 2015
- 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 months to 29 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Males or females, older than 35 months and less than 20 years of age.
- Parent/guardian or alert subject (age 18 or over) capable of giving consent; subject less than 18 and of assent age must give assent to participate if appropriate and required by the institution. If the subjects are incapable of giving assent, then only parent/guardian consent is required.
- Possess an unambiguously identifiable chronically indwelling ventricular shunt which crosses the clavicle.
- Suspicion of shunt obstruction is great enough to warrant the performance of any diagnostic test for this condition
- Will be available for follow-up for up to 7 days
Who cannot join
- Inability or unwillingness of the parent/guardian or alert subject to give informed consent/assent (when appropriate) as required by the Institutional Review Board.
- Presence of multiple shunts or known non-functioning shunts crossing the clavicle.
- Evaluating staff rule out shunt obstruction on the basis of a physical/clinical examination.
- SCMP test would interfere with emergent subject care or if the subject is scheduled to go the OR in short order.
- Presence of an interfering open wound or edema over the shunt.
- Likelihood, in the judgment of the investigator, of the subject being lost to follow-up as a result of subject unavailability or clinical outcome being unobtainable.
- Any other condition that would preclude or bias the results of the study according to the judgment of the investigator.
- Judgment of the investigator that participation in the study will interfere with, or be detrimental to, administration of optimal health-care to the subject.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites, 11 recruiting
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
George I Jallo, MD, 410-955-7851, gjallo1@jhmi.edu
George I Jallo, MD
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Joseph R Madsen, MD, 617-355-6005, Joseph.Madsen@childrens.harvard.edu
Eun Hyoung Park, 617.355.6558, Eun-Hyoung.Park@childrens.harvard.edu
- Recruiting
University of Chicago Comer Children's Hospital
Chicago, Illinois, 60637
David Frim, MD, 773-702-2475, dfrim@peds.bsd.uchicago.edu
David Frim, MD
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Julie C Leonard, MD, 631-444-1213, julie.leonard@nationwidechildrens.org
Jeffrey R Leonard, MD
- Recruiting
University of Texas-Houston/Children's Memorial Hermann Hospital
Houston, Texas, 77030
David Sandberg, MD, 713-500-7306, David.I.Sandberg@uth.tmc.edu
David Sandberg, MD
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Phillip B Storm, MD, 215-590-2780, storm@email.chop.edu
Joseph J Zorc, MD, (215) 776-4285, zorc@email.chop.edu
- Recruiting
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Robert W Hickey, MD, 412-692-5052, Robert.Hickey@chp.edu
Mandeep Tamber, MD, Mandeep.Tamber@chp.edu
- Recruiting
Rhode Island Hospital
Providence, Rhode Island, 02903
Blanche Spindell, 401-444-2328, bspindell@lifespan.org
Lisa H Merck, MD MPH
- Recruiting
Stony Brook Medical Center
Stony Brook, New York, 11794
Alina Stroia, 631-632-9028, alina.stroia@stonybrook.edu
David Chesler, MD
- Recruiting
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Ashley Simmons, 301-565-4288, asimmons@childrensnational.org
Robert F Keating, MD
- Recruiting
A I dePont Hospital for Children
Wilmington, Delaware, 19803
Jonathan E Bennett, MD, 301-651-5827, jonathan.bennett@nemours.org
Joseph H Piatt, MD
About this study
Official title: An Operator-Blinded Study of the Efficacy of ShuntCheck-Micro-Pumper, a Non-Invasive Diagnostic Procedure, in Detecting Ventricular Shunt Patency or Occlusion and in Predicting Clinical Outcome in Children and Adolescents Presenting to Emergency Departments and Neurosurgery Clinics
Primary objective is to demonstrate that data collected from ShuntCheck-Micro-Pumper (SCMP) testing results can be used in conjunction with imaging to diagnose shunt patency or obstruction in pediatric/adolescent subjects presenting to an Emergency Department or Neurosurgery Clinic (ED/NC). SCMP results and SCMP results combined with other diagnostic methods, including the Attending Physician's and the Neurosurgeon's clinical judgment will be compared to clinical outcomes within 7 days of ED/NC visit - either shunt obstruction confirmed during shunt revision surgery or shunt patency confirmed by no surgery or patency confirmed in surgery.
- Conditions
- Suspected CSF Shunt Obstruction
- Being tested
- ShuntCheck-Micro-Pumper (SCMP), Imaging
- Keywords
- hydrocephalus, CSF shunt, shunt malfunction, shunt obstruction, ShuntCheck, ShuntCheck-Micro-Pumper
- Medical subject headings
- Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShuntCheck-Micro-Pumper (SCMP)Device
ShuntCheck uses thermal dilution to detect flow in CSF shunts. CSF is cooled transcutaneously with an ice pack and ShuntCheck's thermosensor detects a temperature drop due to CSF flow "downstream" of the ice. Micro-Pumper is a handheld device which vibrates the shunt valve to generate a temporary increase in CSF flow in patent but temporarily non-flowing shunts. This flow increase can be detected by ShuntCheck.
ImagingDevice
Also called CT Scan, MRI
Imaging of ventricle size
| Study group | Role | What they receive |
|---|---|---|
| SCMP plus Imaging | Experimental | SCMP plus Imaging will be compared to clinical outcomes within 7 days of ED/NC visit - either shunt obstruction confirmed during shunt revision surgery or shunt patency confirmed by no surgery or patency confirmed in surgery. Receives: Device: ShuntCheck-Micro-Pumper (SCMP); Device: Imaging |
| Imaging Alone | Active comparator | Imaging alone will be compared to clinical outcomes within 7 days of ED/NC visit - either shunt obstruction confirmed during shunt revision surgery or shunt patency confirmed by no surgery or patency confirmed in surgery. Receives: Device: Imaging |
| SCMP Rule Out for Low Risk Cases | Experimental | SCMP results in patients judged by the physician to be "Unlikely to require shunt surgery" will be compared to clinical outcomes within 7 days of ED/NC visit - either shunt obstruction confirmed during shunt revision surgery or shunt patency confirmed by no surgery or patency confirmed in surgery - to determine Negative Predictive Value in ruling out shunt malfunction Receives: Device: ShuntCheck-Micro-Pumper (SCMP) |
| Imaging Rule for Low Risk Cases | Active comparator | Imaging results in patients judged by the physician to be "Unlikely to require shunt surgery" will be compared to clinical outcomes within 7 days of ED/NC visit - either shunt obstruction confirmed during shunt revision surgery or shunt patency confirmed by no surgery or patency confirmed in surgery - to determine Negative Predictive Value in ruling out shunt malfunction Receives: Device: Imaging |
| SCMP plus Imaging in Uncertain Cases | Experimental | SCMP plus imaging results in patients who are admitted for observation results in patients judged by the physician to be "Unlikely to require shunt surgery" will be compared to clinical outcomes within 7 days of ED/NC visit - either shunt obstruction confirmed during shunt revision surgery or shunt patency confirmed by no surgery or patency confirmed in surgery - to determine Positive and Negative Predictive Value Receives: Device: ShuntCheck-Micro-Pumper (SCMP); Device: Imaging |
| Imaging alone in Uncertain Cases | Active comparator | Imaging results in patients who are admitted for observation results in patients judged by the physician to be "Unlikely to require shunt surgery" will be compared to clinical outcomes within 7 days of ED/NC visit - either shunt obstruction confirmed during shunt revision surgery or shunt patency confirmed by no surgery or patency confirmed in surgery - to determine Positive and Negative Predictive Value Receives: Device: Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy compared with clinical outcomes
SCMP results and SCMP results combined with other diagnostic methods, including the Attending Physician's and the Neurosurgeon's clinical judgment will be compared to clinical outcomes within 7 days of ED/NC visit - either shunt obstruction confirmed during shunt revision surgery or shunt patency confirmed by no surgery or patency confirmed in surgery.
Measured: 7 days
Positive Predictive Value (PPV)
Specifically to demonstrate that SCMP positive (Flow Not Confirmed - FNC) plus imaging positive (enlarged ventricles) results yield a higher positive predictive value than imaging positive alone.
Measured: 7 days
Negative Predictive Value (NPV)
Specifically to demonstrate that SCMP negative (Flow Confirmed - FC) plus imaging negative (non-enlarged ventricles) results yield a higher negative predictive value than imaging negative alone.
Measured: 7 days
Safety
To determine if any adverse events were caused by the device or procedure while using the study device.
Measured: 1 day
Secondary outcomes (2)
Rule Out for Low Risk Cases
To demonstrate that SCMP plus Physician's judgment is comparable to Physician's judgment plus imaging in ruling out shunt malfunction in patients judged to be "Unlikely to require shunt surgery"
Measured: 7 days
Increased PPV and NPV for Uncertain Cases
To demonstrate that SCMP plus imaging results yield higher positive and negative predictive values than imaging alone in patients who are admitted for observation.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionJun 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 Suspected CSF Shunt ObstructionStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NeuroDx Development
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph R Madsen, MD, Study chair, Boston Children's HospitalGeorge I Jallo, MD, Principal investigator, Johns Hopkins UniversityDavid A Frim, MD, Principal investigator, University of Chicago Comer Children's HospitalDavid Sandberg, MD, Principal investigator, University of Texas-Houston/Children's Memorial Hermann HospitalPhillip B Storm, MD, Principal investigator, Children's Hospital of PhiladelphiaJoseph J Zorc, MD, Principal investigator, Children's Hospital of PhiladelphiaRobert W Hickey, MD, Principal investigator, University of PittsburghMandeep Tamber, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01881711
- Sponsor's protocol ID
- NDxDev-SCMP-2013
- Other IDs
- R44NS067772
- Status last verified
- Jun 2015
- First submitted
- 13 Jun 2013
- Last updated
- 23 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
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
- An Operator-Blinded Study of the Efficacy of ShuntCheck-Micro-Pumper, a Non-Invasive Diagnostic Procedure, in Detecting Ventricular Shunt Patency or Occlusion and in Predicting Clinical Outcome in Children and Adolescents Presenting to Emergency Departments and Neurosurgery Clinics
- ClinicalTrials.gov ID
- NCT01881711
- Acronym / sponsor ID
- NDxDev-SCMP-2013
- Conditions
- Suspected CSF Shunt Obstruction
- Keywords
- hydrocephalus, CSF shunt, shunt malfunction, shunt obstruction, ShuntCheck, ShuntCheck-Micro-Pumper
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- NeuroDx DevelopmentIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- May 2013
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 20 Jun 2013 (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.
Primary objective is to demonstrate that data collected from ShuntCheck-Micro-Pumper (SCMP) testing results can be used in conjunction with imaging to diagnose shunt patency or obstruction in pediatric/adolescent subjects presenting to an Emergency Department or Neurosurgery Clinic (ED/NC). SCMP results and SCMP results combined with other diagnostic methods, including the Attending Physician's and the Neurosurgeon's clinical judgment will be compared to clinical outcomes within 7 days of ED/NC visit - either shunt obstruction confirmed during shunt revision surgery or shunt patency confirmed by no surgery or patency confirmed in surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| SCMP plus Imaging | Experimental | Device: ShuntCheck-Micro-Pumper (SCMP), Device: ImagingSCMP plus Imaging will be compared to clinical outcomes within 7 days of ED/NC visit - either shunt obstruction confirmed during shunt revision surgery or shunt patency confirmed by no surgery or patency confirmed in surgery. |
| Imaging Alone | Active comparator | Device: ImagingImaging alone will be compared to clinical outcomes within 7 days of ED/NC visit - either shunt obstruction confirmed during shunt revision surgery or shunt patency confirmed by no surgery or patency confirmed in surgery. |
| SCMP Rule Out for Low Risk Cases | Experimental | Device: ShuntCheck-Micro-Pumper (SCMP)SCMP results in patients judged by the physician to be "Unlikely to require shunt surgery" will be compared to clinical outcomes within 7 days of ED/NC visit - either shunt obstruction confirmed during shunt revision surgery or shunt patency confirmed by no surgery or patency confirmed in surgery - to determine Negative Predictive Value in ruling out shunt malfunction |
| Imaging Rule for Low Risk Cases | Active comparator | Device: ImagingImaging results in patients judged by the physician to be "Unlikely to require shunt surgery" will be compared to clinical outcomes within 7 days of ED/NC visit - either shunt obstruction confirmed during shunt revision surgery or shunt patency confirmed by no surgery or patency confirmed in surgery - to determine Negative Predictive Value in ruling out shunt malfunction |
| SCMP plus Imaging in Uncertain Cases | Experimental | Device: ShuntCheck-Micro-Pumper (SCMP), Device: ImagingSCMP plus imaging results in patients who are admitted for observation results in patients judged by the physician to be "Unlikely to require shunt surgery" will be compared to clinical outcomes within 7 days of ED/NC visit - either shunt obstruction confirmed during shunt revision surgery or shunt patency confirmed by no surgery or patency confirmed in surgery - to determine Positive and Negative Predictive Value |
| Imaging alone in Uncertain Cases | Active comparator | Device: ImagingImaging results in patients who are admitted for observation results in patients judged by the physician to be "Unlikely to require shunt surgery" will be compared to clinical outcomes within 7 days of ED/NC visit - either shunt obstruction confirmed during shunt revision surgery or shunt patency confirmed by no surgery or patency confirmed in surgery - to determine Positive and Negative Predictive Value |
Who may qualify
- Ages
- 35 months to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Males or females, older than 35 months and less than 20 years of age.
- Parent/guardian or alert subject (age 18 or over) capable of giving consent; subject less than 18 and of assent age must give assent to participate if appropriate and required by the institution. If the subjects are incapable of giving assent, then only parent/guardian consent is required.
- Possess an unambiguously identifiable chronically indwelling ventricular shunt which crosses the clavicle.
- Suspicion of shunt obstruction is great enough to warrant the performance of any diagnostic test for this condition
- Will be available for follow-up for up to 7 days
Key exclusion criteria (8 listed)
- Inability or unwillingness of the parent/guardian or alert subject to give informed consent/assent (when appropriate) as required by the Institutional Review Board.
- Presence of multiple shunts or known non-functioning shunts crossing the clavicle.
- Evaluating staff rule out shunt obstruction on the basis of a physical/clinical examination.
- SCMP test would interfere with emergent subject care or if the subject is scheduled to go the OR in short order.
- Presence of an interfering open wound or edema over the shunt.
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-Micro-Pumper (SCMP)ShuntCheck uses thermal dilution to detect flow in CSF shunts. CSF is cooled transcutaneously with an ice pack and ShuntCheck's thermosensor detects a temperature drop due to CSF flow "downstream" of the ice. Micro-Pumper is a handheld device which vibrates the shunt valve to generate a temporary increase in CSF flow in patent but temporarily non-flowing shunts. This flow increase can be detected by ShuntCheck. | Device | SCMP Rule Out for Low Risk Cases, SCMP plus Imaging, SCMP plus Imaging in Uncertain Cases |
| ImagingAlso: CT Scan, MRIImaging of ventricle size | Device | Imaging Alone, Imaging Rule for Low Risk Cases, Imaging alone in Uncertain Cases, SCMP plus Imaging, SCMP plus Imaging in Uncertain Cases |
Primary outcome
Diagnostic accuracy compared with clinical outcomes
Time frame: 7 days
SCMP results and SCMP results combined with other diagnostic methods, including the Attending Physician's and the Neurosurgeon's clinical judgment will be compared to clinical outcomes within 7 days of ED/NC visit - either shunt obstruction confirmed during shunt revision surgery or shunt patency confirmed by no surgery or patency confirmed in surgery.
Positive Predictive Value (PPV)
Time frame: 7 days
Specifically to demonstrate that SCMP positive (Flow Not Confirmed - FNC) plus imaging positive (enlarged ventricles) results yield a higher positive predictive value than imaging positive alone.
Negative Predictive Value (NPV)
Time frame: 7 days
Specifically to demonstrate that SCMP negative (Flow Confirmed - FC) plus imaging negative (non-enlarged ventricles) results yield a higher negative predictive value than imaging negative alone.
Safety
Time frame: 1 day
To determine if any adverse events were caused by the device or procedure while using the study device.
2 secondary outcomes
Rule Out for Low Risk Cases
Time frame: 7 days
Increased PPV and NPV for Uncertain Cases
Time frame: 7 days
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.
- Conducting a ShuntCheck TestLink provided by the sponsor.
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 study chair
Boston Children's Hospital
George I Jallo, MD principal investigator
Johns Hopkins University
David A Frim, MD principal investigator
University of Chicago Comer Children's Hospital
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ShuntCheck-Micro-Pumper (SCMP) and Imaging in people with Suspected CSF Shunt Obstruction, run by NeuroDx Development at 11 sites 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 5 inclusion and 8 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 11 sites 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?
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?
Diagnostic accuracy compared with clinical outcomes (time frame: 7 days). The study lists 4 primary outcomes in all. 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.