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

University of South Florida

Status: Enrolling

Conditions: Hydrocephalus, Normal Pressure

Treatments: Diagnostic Test: ShuntCheck

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04309487

Pro00041345

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

20 participants in 1 patient group

ShuntCheck

Description:

Participants will be administered the ShuntCheck diagnostic test.

Treatment:

Diagnostic Test: ShuntCheck