Recruiting

ShuntCheck

Sponsor:

University of South Florida

Code:

NCT04309487

Conditions

Hydrocephalus, Normal Pressure

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

ShuntCheck

Study Details

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.

Conditions

Hydrocephalus, Normal Pressure

Study ID

NCT04309487

Start date

Jan 24, 2020

Status verified date

May, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

ShuntCheck

Participants will be administered the ShuntCheck diagnostic test.

Interventions

ShuntCheck

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

Primary outcome measure

  • Sensitivity of ShuntCheck compared to radionuclide shunt patency study [ Time Frame: 15 minutes ]
  • Negative Predictive Value of ShuntCheck compared to radionuclide shunt patency study [ Time Frame: 60 Minutes ]

Central Contacts and Locations

Central contacts

Naomi Abel, MD

813 259-0904nabel@usf.edu

Thanh Tran, MD

813 8448544tqtran@usf.edu

Locations

University of South Florida Department of Neurological Surgery and Brain Repair

Recruiting

Tampa, Florida, United States, 33606

Contacts

Naomi Abel, MD

813 259-0904nabel@usf.edu

Konrad Bach, MD

813 259-8898kbach@usf.edu

Principal Investigator:

Naomi Abel, MD

More Information

Sponsor

University of South Florida

Last update posted

May 18, 2026

Last verified

May, 2026

Keywords

  • Asymptomatic Normal Pressure Hydrocephalus
  • Ventriculoperitoneal Shunt

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Florida on 2026-05-18.