CRT ShuntCheck “Fit & Function” Study

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Brief Title

CRT ShuntCheck "Fit & Function" Study

Official Title

CRT ShuntCheck "Fit & Function" Exploratory Study

Brief 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. 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 Type

Interventional


Primary Outcome

Sensor fit & function

Secondary Outcome

 Identify any safety issues

Condition

Hydrocephalus

Intervention

Fit & Function test

Study Arms / Comparison Groups

 Fit & function test
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

20

Start Date

January 2014

Completion Date

August 2015

Primary Completion Date

July 2015

Eligibility Criteria

        Inclusion Criteria:

          1. For the pediatric subjects, males or females, older than three and less than 20 years
             of age.

          2. For the adult subjects, males or females, older than 35 years of age

          3. 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.

          4. Possess an unambiguously identifiable chronically indwelling ventricular shunt which
             crosses the clavicle.

        Exclusion Criteria:

          1. Inability or unwillingness of the parent/guardian or alert subject to give informed
             consent/assent (when appropriate) as required by the Institutional Review Board.

          2. Study testing would interfere with emergent subject care or if the subject is
             scheduled to go the OR in short order.

          3. Presence of an interfering open wound or edema over the shunt.
      

Gender

All

Ages

3 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02067364

Organization ID

NDxDev-CRT-2015

Secondary IDs

R44NS074486

Responsible Party

Sponsor

Study Sponsor

NeuroDx Development

Collaborators

 National Institute of Neurological Disorders and Stroke (NINDS)

Study Sponsor

, , 


Verification Date

June 2015