Assessment of ShuntCheck Performance Characteristics in A... | NCT04011566

Studies
Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Normal Pressure Hydrocephalus

NCT04011566

Sponsor

University of South Florida

Status

Recruiting

Last Update Posted

May 19, 2026Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Hydrocephalus, Normal Pressure

Interventions

ShuntCheck

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 11, 2019Actual

Primary Completion Date

Nov 2026Estimated

Completion Date

Nov 2026Estimated

First Submitted Date

Jun 18, 2019

First Submission Date that Met QC Criteria

Jul 3, 2019

First Posted Date

Jul 8, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 14, 2026

Last Update Posted Date

May 19, 2026Actual

Name	Class
NeuroDx Development	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ShuntCheck		Participants will be administered the ShuntCheck diagnostic test.	Diagnostic Test: ShuntCheck

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ShuntCheck	Diagnostic Test	The intervention is an FDA-cleared device utilizing a transcutaneous thermal convection to analyze shunt flow.	ShuntCheck

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Specificity of ShuntCheck test		15 minutes
Negative Predictive Value of ShuntCheck test		15 minutes

Secondary Outcomes

Measure	Description	Time Frame
Specificity of performing ShuntCheck test twice		60 minutes
Negative Predictive Value of performing ShuntCheck test twice		60 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The study population will consist of asymptomatic normal pressure hydrocephalus research subjects who have a ventriculoperitoneal shunt with a single ventricular catheter implanted for adult hydrocephalus and are visiting for routine care. Evaluation will be within 2 weeks of shunt placement.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Naomi Abel, MD	Contact	813 259-0904		nabel@usf.edu
Rachel Karlnoski, MD	Contact	813 974 8558		Karlnosk@usf.edu

Overall Officials

Name	Affiliation	Role
Naomi Abel, MD	University of South Florida	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of South Florida Department of Neurological Surgery and Brain Repair	Recruiting	Tampa	Florida	33606	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

individual participant data that underlies the results reported after deidentification and statistical analysis will be shared following publication for 5 years with researchers who provide a methodologically sound proposal

Types

Clinical Study Report (CSR)

Time Frame

Access Criteria

data use agreement required and methodologically sound proposal

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006850	Hydrocephalus, Normal Pressure

Ancestor Terms

ID	Term
D006849	Hydrocephalus
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided