Clinical trial NCT01323764: ShuntCheck Versus Radionuclide in Evaluating Shunt Function in Symptomatic NPH Patients
Official title: A Double- Blinded Comparison of the Accuracy of ShuntCheck, a Non-Invasive Device, to Radionuclide Shunt Patency Test in Evaluating Shunt Function in Patients With Adult Hydrocephalus With Possible Shunt Obstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hydrocephalus
Keywords: Hydrocephalus
CSF shunts
Normal Pressure Hydrocephalus
NPH
ShuntCheck
Shunt Malfunction
Suspected shunt malfunction in adult hydrocephalus patients
Lead sponsor: NeuroDx Development
Sponsor class: INDUSTRY
Collaborators: name: Sinai Hospital of Baltimore
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2011-03-28
Enrollment: 20
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed description: The primary objective is to demonstrate that the accuracy of SC and SC+MP for determining whether a VP shunt is patent or obstructed is statistically no different than the accuracy of the accepted standard test, radionuclide shunt patency study, when performed simultaneously.

A secondary objective is to determine SC and SC+MP results in the presence of possible partial obstruction, which defined as subjects with radionuclide clearance measured by T1/2 of 8 to 10 minutes.

A secondary objective is to compare ShuntCheck flow rate results to simultaneous radionuclide clearance as measured by T1/2. A secondary objective is to demonstrate that ShuntCheck flow rate results are statistically equivalent to simultaneous radionuclide clearance measured by T1/2

Eligibility criteria: Inclusion Criteria:

1. Adult men or women \> 35 years of age;
2. 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;
3. Possess a shunt placed for AH;
4. A radionuclide shunt patency study has been ordered because of suspected shunt obstruction
5. Subject is willing and able to return to the treating physician for evaluation of the outcome of the shunt patency study

Exclusion Criteria:

1. 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;
2. ShuntCheck test would interfere with standard patient care, or emergency shunt surgery that cannot be delayed is indicated;
3. Presence of an interfering open wound or edema over any portion of the VP shunt;
4. Subject is unwilling or unable to return to the treating physician for the SPS and ShuntCheck testing.

Primary outcomes:
measure: Sensitivity and specificity of ShuntCheck vs SPS
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore, LifeBridge Health
state: Maryland
Study officials:
affiliation: Sinai Hospital of Baltimore, LifeBridge Health
name: Michael A Williams, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: NeuroDx Development
name: Sherman C Stein, MD
role: STUDY_CHAIR
affiliation: NeuroDx Development
name: Marek Swoboda, PhD
role: STUDY_DIRECTOR
References: