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

NCT04011566 | Unknown

• 1 other identifier: Pro00040697
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Asymptomatic Normal Pressure Hydrocephalus; Ventriculoperitoneal Shunt

Outcome Measures

Primary Outcomes (2)

• Specificity of ShuntCheck test

  15 minutes

• Negative Predictive Value of ShuntCheck test

  15 minutes

Secondary Outcomes (2)

• Specificity of performing ShuntCheck test twice

  60 minutes

• Negative Predictive Value of performing ShuntCheck test twice

  60 minutes

Study Arms (1)

ShuntCheck

Participants will be administered the ShuntCheck diagnostic test.

Diagnostic Test: ShuntCheck

Interventions

ShuntCheck DIAGNOSTIC_TEST

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

ShuntCheck

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of South Florida: lead
• NeuroDx Development: collaborator

Study Sites (1)

University of South Florida Department of Neurological Surgery and Brain Repair

Tampa, Florida, 33606, United States

RECRUITING

MeSH Terms

Conditions

Hydrocephalus, Normal Pressure

Condition Hierarchy (Ancestors)

Hydrocephalus; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Naomi Abel, MD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naomi Abel, MD

CONTACT

813 259-0904; nabel@usf.edu

Rachel Karlnoski, MD

CONTACT

813 974 8558; Karlnosk@usf.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, College of Medicine Neurosurgery

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: July 8, 2019
• Study Start: June 11, 2019
• Primary Completion: June 1, 2024
• Study Completion: January 1, 2025
• Last Updated: September 30, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 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
• Access Criteria: data use agreement required and methodologically sound proposal

Locations

US (1)