ShuntCheck Performance Characteristics in Asymptomatic Pseudotumor Cerebri Patients

University of South Florida

Status

Enrolling

Conditions

Pseudotumor Cerebri

Treatments

Diagnostic Test: ShuntCheck

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT04309383

Pro00042422

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 pseudotumor cerebri.

Full description

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 pseudotumor cerebri.

Flow may be limited due to slit ventricles

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

18 years old or older Adult men or women who possess a VP shunt placed for PTC;
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;
Subjects will be asymptomatic visiting for routine care at 2-4 weeks post op

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.