Diagnostic Accuracy of ShuntCheck Compared to Radionuclide Shunt: Patency in Patients With Normal Pressure Hydrocephalus

Diagnostic Accuracy of ShuntCheck Compared With Radionuclide Shunt Patency Test to Detect Shunt Flow Obstruction in Patients With Normal Pressure Hydrocephalus - A Cross-sectional Analytic Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04309487

Enrollment

Registered

2020-03-16

Start date

2020-01-24

Completion date

2027-01-01

Last updated

2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hydrocephalus, Normal Pressure

Keywords

Asymptomatic Normal Pressure Hydrocephalus, Ventriculoperitoneal Shunt

Brief summary

The purpose of this study is to assess the diagnostic accuracy of ShuntCheck compared with radionuclide shunt patency testing (SPS) to detect CSF shunt flow of NPH patients with suspected shunt obstruction.

Detailed description

Interventions

DIAGNOSTIC_TESTShuntCheck

The intervention is an FDA-cleared device utilizing a transcutaneous thermal convection to analyze shunt flow.

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Inclusion criteria

* Men or women 40 yo or older and have a VP shunt placed for NPH and are suspected of shunt obstruction. * 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

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.

Design outcomes

Primary

Measure	Time frame
Sensitivity of ShuntCheck compared to radionuclide shunt patency study	15 minutes
Negative Predictive Value of ShuntCheck compared to radionuclide shunt patency study	60 Minutes

Countries

United States

Contacts

CONTACTNaomi Abel, MD

nabel@usf.edu813 259-0904

CONTACTThanh Tran, MD

tqtran@usf.edu813 8448544

PRINCIPAL_INVESTIGATORNaomi Abel, MD

University of South Florida

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 19, 2026