Assessment of ShuntCheck Performance Characteristics in Asymptomatic 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

NCT04011566

Pro00040697

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 1 patient group

ShuntCheck

Description:

Participants will be administered the ShuntCheck diagnostic test.

Treatment:

Diagnostic Test: ShuntCheck