ShuntCheck Versus Radionuclide in Evaluating Shunt Function in Symptomatic NPH Patients

Hydrocephalus Clinical Trial

— SCNPH  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01323764
• Other study ID #: NDxDev-SCMP-2012
• Secondary ID: R43NS067770-01A1
• Status: Completed
• Phase: Phase 4
• First received: March 21, 2011
• Last updated: October 19, 2015
• Start date: June 2011
• Est. completion date: July 2015

Study information

• Verified date: October 2015
• Source: NeuroDx Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hydrocephalus

Intervention

Device:
• ShuntCheck test
Non-invasive, thermal dilution test for CSF shunt flow compared to radionuclide shunt patency testing

Locations

Country	Name	City	State
United States	Sinai Hospital of Baltimore, LifeBridge Health	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
NeuroDx Development	National Institute of Neurological Disorders and Stroke (NINDS), Sinai Hospital of Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of ShuntCheck vs SPS	The primary efficacy objective is the sensitivity and specificity of the ShuntCheck test.; The performance of ShuntCheck test will be compared to the radionuclide scanning done on the day of ShuntCheck administration. Primary efficacy of the SC and SC+MP test will be determined by comparing SC and SC+MP performance to results of radionuclide scanning according to a standard 2 x 2 table, with a Positive test result defined as evidence of shunt obstruction.	Day 1	No

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