HydrocephalusPhase 4SCNPHNCT01323764

ShuntCheck Versus Radionuclide in Evaluating Shunt Function in Symptomatic NPH Patients

A Phase 4 study testing ShuntCheck test in people with Hydrocephalus, run by NeuroDx Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to compare the accuracy of ShuntCheck (SC) and ShuntCheck plus Micro-Pumper (SC+MP) to radionuclide shunt patency testing (SPS) in evaluating shunt function in patients with adult hydrocephalus (AH) implanted with ventriculoperitoneal (VP) shunts when shunt obstruction is suspected and a… Read more about this study

Who is it for?: Ages 35 years and older
Conditions the study is for: Hydrocephalus
What is being tested?: ShuntCheck test
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: Jun 2011to Jul 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult men or women > 35 years of age;
Capable of providing valid signed informed consent, or has a legal guardian, health care agent, or surrogate decision maker (according to local statutes, and collectively referred to as "surrogates" in this protocol) capable of providing valid, signed informed consent;
Possess a shunt placed for AH;
A radionuclide shunt patency study has been ordered because of suspected shunt obstruction
Subject is willing and able to return to the treating physician for evaluation of the outcome of the shunt patency study

Who cannot join

Presence of multiple shunts, or presence of more than one distal shunt catheter (regardless of function) crossing the clavicle ipsilateral to the shunt with suspected obstruction;
ShuntCheck test would interfere with standard patient care, or emergency shunt surgery that cannot be delayed is indicated;
Presence of an interfering open wound or edema over any portion of the VP shunt;
Subject is unwilling or unable to return to the treating physician for the SPS and ShuntCheck testing.

Trial locations and contacts

1 site in 1 country.

United States1 site

Sinai Hospital of Baltimore, LifeBridge Health
Baltimore, Maryland, 21215

Other trials in United States

About this study

Official title: A Double- Blinded Comparison of the Accuracy of ShuntCheck, a Non-Invasive Device, to Radionuclide Shunt Patency Test in Evaluating Shunt Function in Patients With Adult Hydrocephalus With Possible Shunt Obstruction

Read the detailed description

The primary objective is to demonstrate that the accuracy of SC and SC+MP for determining whether a VP shunt is patent or obstructed is statistically no different than the accuracy of the accepted standard test, radionuclide shunt patency study, when performed simultaneously.

A secondary objective is to determine SC and SC+MP results in the presence of possible partial obstruction, which defined as subjects with radionuclide clearance measured by T1/2 of 8 to 10 minutes.

A secondary objective is to compare ShuntCheck flow rate results to simultaneous radionuclide clearance as measured by T1/2. A secondary objective is to demonstrate that ShuntCheck flow rate results are statistically equivalent to simultaneous radionuclide clearance measured by T1/2

Conditions: Hydrocephalus
Being tested: ShuntCheck test
Keywords: Hydrocephalus, CSF shunts, Normal Pressure Hydrocephalus, NPH, ShuntCheck, Shunt Malfunction, Suspected shunt malfunction in adult hydrocephalus patients
Medical subject headings: Hydrocephalus, Hydrocephalus, Normal Pressure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ShuntCheck testDevice
Also called ShuntCheck
Non-invasive, thermal dilution test for CSF shunt flow compared to radionuclide shunt patency testing

Study groups in NCT01323764
Study group	Role	What they receive
Radionuclide SPS	Active comparator	Radionuclide Shunt Patency Study Receives: Device: ShuntCheck test

What is being measured

The primary outcome is the main question the study is designed to answer.

Sensitivity and specificity of ShuntCheck vs SPS
The primary efficacy objective is the sensitivity and specificity of the ShuntCheck test.
The performance of ShuntCheck test will be compared to the radionuclide scanning done on the day of ShuntCheck administration. Primary efficacy of the SC and SC+MP test will be determined by comparing SC and SC+MP performance to results of radionuclide scanning according to a standard 2 x 2 table, with a Positive test result defined as evidence of shunt obstruction.
Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2011Jul 2015

First posted28 Mar 2011 (estimated)
Study startJun 2011
Primary completionJun 2015
Study completionJul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for 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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 20 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01323764
Sponsor's protocol ID: NDxDev-SCMP-2012
Other IDs: R43NS067770-01A1
Acronym: SCNPH
Status last verified: Oct 2015
First submitted: 21 Mar 2011
Last updated: 20 Oct 2015
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Development of Non-Invasive Prenatal Diagnosis for Single Gene Disorders
Invasive PreNatal Diagnosis in a Context of Family History of Single-gene Disorders, Including, Sickle Cell Disease
RecruitingObservational study
Natural History of Treated Neurocysticercosis and Long-Term Outcomes
Cysticercosis, Neurocysticercosis
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
Active, not recruiting
HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants
Hydrocephalus
Not yet recruitingObservational study
Prediction of Response to Shunt Surgery in Normal Pressure Hydrocephalus Using Radscale and Lumbar Puncture
Idiopathic Normal Pressure Hydrocephalus, Normal Pressure Hydrocephalus

All Hydrocephalus trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double- Blinded Comparison of the Accuracy of ShuntCheck, a Non-Invasive Device, to Radionuclide Shunt Patency Test in Evaluating Shunt Function in Patients With Adult Hydrocephalus With Possible Shunt Obstruction
ClinicalTrials.gov ID: NCT01323764
Acronym / sponsor ID: SCNPH / NDxDev-SCMP-2012
Conditions: Hydrocephalus
Keywords: Hydrocephalus, CSF shunts, Normal Pressure Hydrocephalus, NPH, ShuntCheck, Shunt Malfunction, Suspected shunt malfunction in adult hydrocephalus patients
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (estimated)
Lead sponsor: NeuroDx DevelopmentIndustry (pharma, biotech, devices)
Collaborators: Sinai Hospital of Baltimore, National Institute of Neurological Disorders and Stroke (NINDS)
Study start: Jun 2011
Primary completion: Jun 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 28 Mar 2011 (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.

Detailed description

A secondary objective is to determine SC and SC+MP results in the presence of possible partial obstruction, which defined as subjects with radionuclide clearance measured by T1/2 of 8 to 10 minutes.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 1

Arm	Type	Receives
Radionuclide SPS	Active comparator	Device: ShuntCheck testRadionuclide Shunt Patency Study

Who may qualify

Ages: 35 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Adult men or women > 35 years of age;
Capable of providing valid signed informed consent, or has a legal guardian, health care agent, or surrogate decision maker (according to local statutes, and collectively referred to as "surrogates" in this protocol) capable of providing valid, signed informed consent;
Possess a shunt placed for AH;
A radionuclide shunt patency study has been ordered because of suspected shunt obstruction
Subject is willing and able to return to the treating physician for evaluation of the outcome of the shunt patency study

Key exclusion criteria (4 listed)

Presence of multiple shunts, or presence of more than one distal shunt catheter (regardless of function) crossing the clavicle ipsilateral to the shunt with suspected obstruction;
ShuntCheck test would interfere with standard patient care, or emergency shunt surgery that cannot be delayed is indicated;
Presence of an interfering open wound or edema over any portion of the VP shunt;
Subject is unwilling or unable to return to the treating physician for the SPS and ShuntCheck testing.

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 testAlso: ShuntCheckNon-invasive, thermal dilution test for CSF shunt flow compared to radionuclide shunt patency testing	Device	Radionuclide SPS

Primary outcome

Sensitivity and specificity of ShuntCheck vs SPS
Time frame: Day 1
The primary efficacy objective is the sensitivity and specificity of the ShuntCheck test. The performance of ShuntCheck test will be compared to the radionuclide scanning done on the day of ShuntCheck administration. Primary efficacy of the SC and SC+MP test will be determined by comparing SC and SC+MP performance to results of radionuclide scanning according to a standard 2 x 2 table, with a Positive test result defined as evidence of shunt obstruction.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2015.
Related InfoLink provided by the sponsor.

Related trials for Hydrocephalus

RecruitingObservational study
Development of Non-Invasive Prenatal Diagnosis for Single Gene Disorders
Invasive PreNatal Diagnosis in a Context of Family History of Single-gene Disorders, Including, Sickle Cell Disease
RecruitingObservational study
Natural History of Treated Neurocysticercosis and Long-Term Outcomes
Cysticercosis, Neurocysticercosis
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
Active, not recruiting
HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants
Hydrocephalus
Not yet recruitingObservational study
Prediction of Response to Shunt Surgery in Normal Pressure Hydrocephalus Using Radscale and Lumbar Puncture
Idiopathic Normal Pressure Hydrocephalus, Normal Pressure Hydrocephalus

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.

Michael A Williams, MD principal investigator

Sinai Hospital of Baltimore, LifeBridge Health

Sherman C Stein, MD study chair

NeuroDx Development

Marek Swoboda, PhD study director

NeuroDx Development

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 ShuntCheck test in people with 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 20 Oct 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.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Sensitivity and specificity of ShuntCheck vs SPS (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01323764.

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 20 Oct 2015.