Recruiting

CRT ShuntCheck

Sponsor:

NeuroDx Development

Code:

NCT02067364

Conditions

Hydrocephalus

Eligibility Criteria

Sex: All

Age: 3+

Healthy Volunteers: Not accepted

Interventions

Fit & Function test

Study Details

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.

Conditions

Hydrocephalus

Study ID

NCT02067364

Start date

Jan, 2014

Status verified date

Jun, 2015

Completion date

Aug, 2015

Anticipated

Primary completion date

Jul, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Interventions and Outcome Measures

Arms

other: 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.

Interventions

Fit & Function test

Primary outcome measure

  • Sensor fit & function [ Time Frame: Single visit one hour test procedure ]

Central Contacts and Locations

Locations

LifeBridge Health, Sinai Hospital of Baltimore (Testing Adult Patients 35 years+)

Recruiting

Baltimore, Maryland, United States, 21215

Contacts

Principal Investigator:

Michael A Williams, MD

Johns Hopkins Hospital (Testing Pediatric Patients Age 3 to 19)

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Principal Investigator:

George I Jallo, MD

More Information

Sponsor

NeuroDx Development

Last update posted

Jun 23, 2015

Last verified

Jun, 2015

Keywords

  • hydrocephalus
  • CSF shunt

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NeuroDx Development on 2015-06-23.