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Trial record 18 of 44 for:    CSF | "Hydrocephalus"

CRT ShuntCheck "Fit & Function" Study

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ClinicalTrials.gov Identifier: NCT02067364
Recruitment Status : Unknown
Verified June 2015 by NeuroDx Development.
Recruitment status was:  Recruiting
First Posted : February 20, 2014
Last Update Posted : June 23, 2015
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
NeuroDx Development

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.

Condition or disease Intervention/treatment Phase
Hydrocephalus Device: Fit & Function test Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: CRT ShuntCheck "Fit & Function" Exploratory Study
Study Start Date : January 2014
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hydrocephalus

Arm Intervention/treatment
Fit & function test
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.
Device: Fit & Function test
Other Names:
  • ShuntCheck
  • CRT ShuntCheck
  • ShuntCheck XM Extended Shunt Flow Monitor




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Identify any safety issues [ Time Frame: Single visit one hour test ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02067364


Locations
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United States, Maryland
LifeBridge Health, Sinai Hospital of Baltimore (Testing Adult Patients 35 years+) Recruiting
Baltimore, Maryland, United States, 21215
Contact: Michael A Williams, MD    410-601-1900    michwill@lifebridgehealth.org   
Principal Investigator: Michael A Williams, MD         
Johns Hopkins Hospital (Testing Pediatric Patients Age 3 to 19) Recruiting
Baltimore, Maryland, United States, 21287
Contact: George I Jallo, MD    410-955-7851    gjallo1@jhmi.edu   
Principal Investigator: George I Jallo, MD         
Sponsors and Collaborators
NeuroDx Development
National Institute of Neurological Disorders and Stroke (NINDS)

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Responsible Party: NeuroDx Development
ClinicalTrials.gov Identifier: NCT02067364     History of Changes
Other Study ID Numbers: NDxDev-CRT-2015
R44NS074486 ( U.S. NIH Grant/Contract )
First Posted: February 20, 2014    Key Record Dates
Last Update Posted: June 23, 2015
Last Verified: June 2015

Keywords provided by NeuroDx Development:
hydrocephalus
CSF shunt

Additional relevant MeSH terms:
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Hydrocephalus
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases