CompletedPhase 4

ShuntCheck Versus Radionuclide in Evaluating Shunt Function in Symptomatic NPH Patients

United States20 participantsStarted 2011-06

Plain-language summary

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.

Who can participate

Age range35 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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.

What they're measuring

Sensitivity and specificity of ShuntCheck vs SPS

Timeframe: Day 1

Trial details

NCT IDNCT01323764

SponsorNeuroDx Development

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-06

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