ShuntCheck Versus Radionuclide in Evaluating Shunt Function in Symptomatic NPH Patients

Completed · Phase 4

Conditions studied: Hydrocephalus

In brief

The purpose of this study is to compare the accuracy of ShuntCheck (SC) and ShuntCheck plus Micro-Pumper (SC+MP) to radionuclide shunt patency testing (SPS) in evaluating shunt function in patients with adult hydrocephalus (AH) implanted with ventriculoperitoneal (VP) shunts when shunt obstruction is suspected and a diagnostic procedure such as radionuclide shunt patency testing (SPS) is required.

Key facts

Study ID

NCT01323764

Run by

NeuroDx Development

People needed

20

Starts

2011-06-01

Expected to finish

2015-07-01

Last updated by the study team

2015-10-20

Who can join

Age: 35 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult men or women > 35 years of age;
• Capable of providing valid signed informed consent, or has a legal guardian, health care agent, or surrogate decision maker (according to local statutes, and collectively referred to as "surrogates" in this protocol) capable of providing valid, signed informed consent;
• Possess a shunt placed for AH;
• A radionuclide shunt patency study has been ordered because of suspected shunt obstruction
• Subject is willing and able to return to the treating physician for evaluation of the outcome of the shunt patency study

You may not qualify if…

• Presence of multiple shunts, or presence of more than one distal shunt catheter (regardless of function) crossing the clavicle ipsilateral to the shunt with suspected obstruction;
• ShuntCheck test would interfere with standard patient care, or emergency shunt surgery that cannot be delayed is indicated;
• Presence of an interfering open wound or edema over any portion of the VP shunt;
• Subject is unwilling or unable to return to the treating physician for the SPS and ShuntCheck testing.

Where it is running

• Sinai Hospital of Baltimore, LifeBridge Health — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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