CRT ShuntCheck "Fit & Function" Study

NCT02067364 | Unknown DMC

• 2 other identifiers: NDxDev-CRT-2015R44NS074486
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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

Keywords

hydrocephalus; CSF shunt

Outcome Measures

Primary Outcomes (1)

• 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

  Single visit one hour test procedure

Secondary Outcomes (1)

• Identify any safety issues

  Single visit one hour test

Study Arms (1)

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.

Device: Fit & Function test

Interventions

Fit & Function test DEVICE

Also known as: ShuntCheck, CRT ShuntCheck, ShuntCheck XM Extended Shunt Flow Monitor

Fit & function test

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NeuroDx Development: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (2)

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

Baltimore, Maryland, 21215, United States

RECRUITING

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

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Hydrocephalus

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2014
• First Posted: February 20, 2014
• Study Start: January 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: June 23, 2015

Record last verified: 2015-06

Locations

US (2)