ShuntCheck Outcomes Study
Please note that enrollment for this study has ended.
What is the purpose of the study?
The purpose of this research study is to find out if a patient’s shunt is working properly at the doctor’s office or in the emergency department using the diagnostic test, ShuntCheck III. It is the first device which measures shunt flow using a simple test on the patient’s skin, and is not invasive. The usefulness of ShuntCheck III in identifying shunt blockage and in predicting whether or not the patient needs surgery is being studied.
Who can participate in the study?
This study pertains to all patients between 3 and 30 years old with a single ventricular shunt which crosses the clavicle and who presents to the emergency department or the neurosurgery clinic.
What will happen during the study?
After informed consent/assent is obtained, study personnel will use ice packs and a warm pack over the patient’s skin in order to change the temperature of the fluid running through the patient’s shunt. A small handheld device will then be placed against the patient’s head over their shunt valve, and will vibrate gently for 60 seconds in order to increase the shunt fluid movement. The temperature and movement of fluid in the shunt will be recorded. This completely noninvasive test will take approximately 20-25 minutes, and the results will be blinded to the research and medical staff. Within 7 days of completing this study, a study staff member may contact the patient or the physician to find out if a surgical procedure was done on the patient’s shunt, and if so, what was found during surgery.
Who can I contact if I am interested or if I have any questions?