CClinicalTrials.gg
Sign In
RecruitingNCT04309487Updated May 18, 2026

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

An observational study in Hydrocephalus, Normal Pressure, sponsored by University of South Florida. Recruiting at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-05-18.

Sponsored by University of South Florida · Observational

From the registry’s dates

  • Started Jan 2020; still recruiting 6 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
20
Ages
40 Years and older
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Hydrocephalus, Normal Pressure

Keywords

  • Asymptomatic Normal Pressure Hydrocephalus
  • Ventriculoperitoneal Shunt
03

In context

Hydrocephalus, Normal Pressure

71 studies on the registry are indexed under Hydrocephalus, Normal Pressure; 17 are open to participants now.

This study's planned enrollment of 20 is below the median of 50 across 32 observational studies indexed under Hydrocephalus, Normal Pressure.

Browse Hydrocephalus, Normal Pressure studies →

Lead sponsor

University of South Florida is the lead sponsor of 333 studies on the registry; 63 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

The study population will consist of NPH hydrocephalus research subjects who have a VP shunt with a single ventricular catheter implanted for adult hydrocephalus are suspected of shunt obstruction and are scheduled for a radionuclide SPS.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
20 participants (estimated)
Patient registry
No

Groups and cohorts

  • ShuntCheck

    Participants will be administered the ShuntCheck diagnostic test.

    Diagnostic Test: ShuntCheck

Interventions

  • Diagnostic testShuntCheck

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

06

What researchers measure

Primary outcomes

  1. Sensitivity of ShuntCheck compared to radionuclide shunt patency study

    Time frame: 15 minutes

  2. Negative Predictive Value of ShuntCheck compared to radionuclide shunt patency study

    Time frame: 60 Minutes

07

Study locations

1 of 1 sites recruiting
  • University of South Florida Department of Neurological Surgery and Brain Repair
    Tampa, Florida 33606, United States
    • Naomi Abel, MD · Contact · nabel@usf.edu · 813 259-0904
    • Konrad Bach, MD · Contact · kbach@usf.edu · 813 259-8898
    • Naomi Abel, MD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — At present there is no plan to share any individual participant data.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04309487
Lead sponsor
University of South Florida
Collaborators
NeuroDx Development
Responsible party
Naomi Abel (Assistant Professor, College of Medicine Neurosurgery, University of South Florida) — Principal investigator
First posted
Mar 16, 2020
Start date
Jan 24, 2020
Primary completion
Jan 2027 (estimated)
Completion
Jan 2027 (estimated)
Last update
May 18, 2026

Study contacts

Naomi Abel, MD
Contact
nabel@usf.edu
813 259-0904
Thanh Tran, MD
Contact
tqtran@usf.edu
813 8448544
Naomi Abel, MD
principal investigator · University of South Florida

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hydrocephalus, Normal Pressure→

Other studies from this sponsor

University of South Florida

Start the discussion