ShuntCheck Versus Radionuclide in Evaluating Shunt Function in Symptomatic NPH Patients (SCNPH)
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
Studie Overzicht
Gedetailleerde beschrijving
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
Studietype
Inschrijving (Verwacht)
Fase
- Fase 4
Contacten en locaties
Studie Locaties
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21215
- Sinai Hospital of Baltimore, LifeBridge Health
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: Radionuclide SPS
Radionuclide Shunt Patency Study
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Non-invasive, thermal dilution test for CSF shunt flow compared to radionuclide shunt patency testing
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Sensitivity and specificity of ShuntCheck vs SPS
Tijdsspanne: Day 1
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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
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Michael A Williams, MD, Sinai Hospital of Baltimore, LifeBridge Health
- Studie stoel: Sherman C Stein, MD, NeuroDx Development
- Studie directeur: Marek Swoboda, PhD, NeuroDx Development
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- NDxDev-SCMP-2012
- R43NS067770-01A1 (Subsidie/contract van de Amerikaanse NIH)
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