HydrocephalusNCT02067364
CRT ShuntCheck "Fit & Function" Study
A study testing Fit & Function test in people with Hydrocephalus, run by NeuroDx Development at 2 sites in United States.
Trial summary
An exploratory "Fit \& Function" study of Continuous Real Time (CRT) ShuntCheck, a non-invasive method for monitoring changes in cerebrospinal fluid (CSF) shunt flow in hydrocephalus patients. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Hydrocephalus
- What is being tested?
- Fit & Function test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2014to Aug 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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- For the pediatric subjects, males or females, older than three and less than 20 years of age.
- For the adult subjects, males or females, older than 35 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.
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.
- Study testing 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
LifeBridge Health, Sinai Hospital of Baltimore (Testing Adult Patients 35 years+)
Baltimore, Maryland, 21215
Michael A Williams, MD, 410-601-1900, michwill@lifebridgehealth.org
Michael A Williams, MD
- Recruiting
Johns Hopkins Hospital (Testing Pediatric Patients Age 3 to 19)
Baltimore, Maryland, 21287
George I Jallo, MD, 410-955-7851, gjallo1@jhmi.edu
George I Jallo, MD
About this study
Official title: CRT ShuntCheck "Fit & Function" Exploratory Study
An exploratory "Fit \& Function" study of Continuous Real Time (CRT) ShuntCheck, a non-invasive method for monitoring changes in cerebrospinal fluid (CSF) shunt flow in hydrocephalus patients. The device will be tested on 10 pediatric patients (at Johns Hopkins Hospital) and 10 adult patients (at LifeBridge Health) and results will be used to optimize device design.
Read the detailed description
An exploratory "Fit \& Function" study of Continuous Real Time (CRT) ShuntCheck, a non-invasive method for monitoring changes in CSF shunt flow in hydrocephalus patients. This study will gather information to refine the design of the CRT ShuntCheck sensor. Our Aim I product work will yield a clinic-ready prototype which adheres well to human skin, conforms to the curve surface of the clavicle and provides a safe level of skin cooling over an extended period of time. Many of the clinical uses of CRT will involve patient movement - standing up to investigate suspected overdrainage, or the simple fidgeting of children undergoing monitoring. The Aim II Fit and Function testing will most importantly identify movement-related product performance issues. If we can identify the causes of "signal noise", we can modify our sensor design to make it less susceptible to "motion artifacts".
Additionally testing will identify age/size specific issues - is the sensor small enough for use on younger children, does the looser skin of older adults generate move motion artifacts in the signal.
These studies will include 10 pediatric and 10 adult asymptomatic patients who are willing to undergo CRT ShuntCheck testing over a one hour period. Test results will not be used to guide patient care and testing will not interfere with or delay any other patient testing or care.
- Conditions
- Hydrocephalus
- Being tested
- Fit & Function test
- Keywords
- hydrocephalus, CSF shunt
- Medical subject headings
- Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fit & Function testDevice
Also called ShuntCheck, CRT ShuntCheck, ShuntCheck XM Extended Shunt Flow Monitor
| Study group | Role | What they receive |
|---|---|---|
| Fit & function test | Other | CRT ShuntCheck sensors will be applied over the shunts of asymptomatic hydrocephalus patients. The device will be activated, cooling the skin under the sensor. Patients will change positions during the one hour procedure and data will be recorded. Data will be analyzed offline to identify product performance issues due to motion. Receives: Device: Fit & Function test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensor fit & function
Fit and Function testing will quantify the level and the duration of thermal changes due to patient movement compared with the level and duration of thermal changes due to changes in shunt flow. If motion related changes are > 0.5 times the level of flow related changes, the sensor and/or the procedure will be modified to improve signal to noise to >2.0
Measured: Single visit one hour test procedure
Secondary outcomes (1)
Identify any safety issues
The CRT ShuntCheck test is a non-invasive, non-significant risk procedure. A small area of skin at the clavicle is cooled to and held at room temperature for an extended period of time. Study subjects should experience zero significant adverse events and no temperature related adverse events beyond minor discomfort. Any EA's will be addressed in design modifications.
Measured: Single visit one hour test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionJul 2015 (estimated)
- Study completionAug 2015 (estimated)
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 N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NeuroDx Development
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02067364
- Sponsor's protocol ID
- NDxDev-CRT-2015
- Other IDs
- R44NS074486
- Status last verified
- Jun 2015
- First submitted
- 17 Feb 2014
- 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
- CRT ShuntCheck "Fit & Function" Exploratory Study
- ClinicalTrials.gov ID
- NCT02067364
- Acronym / sponsor ID
- NDxDev-CRT-2015
- Conditions
- Hydrocephalus
- Keywords
- hydrocephalus, CSF shunt
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- NeuroDx DevelopmentIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Jan 2014
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 20 Feb 2014 (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.
An exploratory "Fit \& Function" study of Continuous Real Time (CRT) ShuntCheck, a non-invasive method for monitoring changes in cerebrospinal fluid (CSF) shunt flow in hydrocephalus patients. The device will be tested on 10 pediatric patients (at Johns Hopkins Hospital) and 10 adult patients (at LifeBridge Health) and results will be used to optimize device design.
Detailed description
An exploratory "Fit \& Function" study of Continuous Real Time (CRT) ShuntCheck, a non-invasive method for monitoring changes in CSF shunt flow in hydrocephalus patients. This study will gather information to refine the design of the CRT ShuntCheck sensor. Our Aim I product work will yield a clinic-ready prototype which adheres well to human skin, conforms to the curve surface of the clavicle and provides a safe level of skin cooling over an extended period of time. Many of the clinical uses of CRT will involve patient movement - standing up to investigate suspected overdrainage, or the simple fidgeting of children undergoing monitoring. The Aim II Fit and Function testing will most importantly identify movement-related product performance issues. If we can identify the causes of "signal noise", we can modify our sensor design to make it less susceptible to "motion artifacts".
Additionally testing will identify age/size specific issues - is the sensor small enough for use on younger children, does the looser skin of older adults generate move motion artifacts in the signal.
These studies will include 10 pediatric and 10 adult asymptomatic patients who are willing to undergo CRT ShuntCheck testing over a one hour period. Test results will not be used to guide patient care and testing will not interfere with or delay any other patient testing or care.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fit & function test | Other | Device: Fit & Function testCRT ShuntCheck sensors will be applied over the shunts of asymptomatic hydrocephalus patients. The device will be activated, cooling the skin under the sensor. Patients will change positions during the one hour procedure and data will be recorded. Data will be analyzed offline to identify product performance issues due to motion. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- For the pediatric subjects, males or females, older than three and less than 20 years of age.
- For the adult subjects, males or females, older than 35 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.
Key exclusion criteria (3 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.
- Study testing 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 |
|---|---|---|
| Fit & Function testAlso: ShuntCheck, CRT ShuntCheck, ShuntCheck XM Extended Shunt Flow Monitor | Device | Fit & function test |
Primary outcome
Sensor fit & function
Time frame: Single visit one hour test procedure
Fit and Function testing will quantify the level and the duration of thermal changes due to patient movement compared with the level and duration of thermal changes due to changes in shunt flow. If motion related changes are > 0.5 times the level of flow related changes, the sensor and/or the procedure will be modified to improve signal to noise to >2.0
1 secondary outcome
Identify any safety issues
Time frame: Single visit one hour test
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.
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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.
LifeBridge Health, Sinai Hospital of Baltimore (Testing Adult Patients 35 years+)
Baltimore, United States
Johns Hopkins Hospital (Testing Pediatric Patients Age 3 to 19)
Baltimore, United States
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fit & Function test in people with Hydrocephalus, run by NeuroDx Development at 2 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 4 inclusion and 3 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 2 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensor fit & function (time frame: Single visit one hour test procedure). 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.