Recruiting

ShuntCheck

Sponsor:

University of South Florida

Code:

NCT04011566

Conditions

Hydrocephalus, Normal Pressure

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

ShuntCheck

Study Details

Brief summary:

The purpose of the study is to determine if the ShuntCheck test can correctly identify flow or no flow in a ventriculoperitoneal shunt in patients with asymptomatic normal pressure hydrocephalus.

Conditions

Hydrocephalus, Normal Pressure

Study ID

NCT04011566

Start date

Jun 11, 2019

Status verified date

May, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Asymptomatic men or women 40 years old or older and have a ventriculoperitoneal shunt placed for normal pressure hydrocephalus and are visiting for routine care.
  • Capable of providing valid signed informed consent, or has a legal guardian, health care agent, or surrogate decision maker 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 ventriculoperitoneal shunt.

Study Design

Enrollment

50 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

  • Specificity of ShuntCheck test [ Time Frame: 15 minutes ]
  • Negative Predictive Value of ShuntCheck test [ Time Frame: 15 minutes ]

Central Contacts and Locations

Central contacts

Naomi Abel, MD

813 259-0904nabel@usf.edu

Rachel Karlnoski, MD

813 974 8558Karlnosk@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@health.usf.edu

Principal Investigator:

Naomi Abel, MD

More Information

Sponsor

University of South Florida

Last update posted

May 19, 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 2026-05-19.