CRT ShuntCheck "Fit & Function" Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|Condition or disease||Intervention/treatment||Phase|
|Hydrocephalus||Device: Fit & Function test||Not Applicable|
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 (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|
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
- 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
- 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.
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
|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 email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator: George I Jallo, MD|