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

NCT04309487 | Unknown

• 1 other identifier: Pro00041345
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Asymptomatic Normal Pressure Hydrocephalus; Ventriculoperitoneal Shunt

Outcome Measures

Primary Outcomes (2)

• Sensitivity of ShuntCheck compared to radionuclide shunt patency study

  15 minutes

• Negative Predictive Value of ShuntCheck compared to radionuclide shunt patency study

  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
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

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 VP 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

Thanh Tran, MD

CONTACT

813 8448544; tqtran@usf.edu

Study Design

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

Study Record Dates

• First Submitted: March 12, 2020
• First Posted: March 16, 2020
• Study Start: January 24, 2020
• Primary Completion: June 1, 2024
• Study Completion: January 1, 2025
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)