NCT04011566 Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Normal Pressure Hydrocephalus
| NCT ID | NCT04011566 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of South Florida |
| Condition | Hydrocephalus, Normal Pressure |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2019-06-11 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2019-06-11 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Naomi Abel, MD
PRINCIPAL INVESTIGATOR
University of South Florida
Frequently Asked Questions
Who can join the NCT04011566 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Hydrocephalus, Normal Pressure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04011566 currently recruiting?
Yes, NCT04011566 is actively recruiting participants. Contact the research team at nabel@usf.edu for enrollment information.
Where is the NCT04011566 trial being conducted?
This trial is being conducted at Tampa, United States.
Who is sponsoring the NCT04011566 clinical trial?
NCT04011566 is sponsored by University of South Florida. The principal investigator is Naomi Abel, MD at University of South Florida. The trial plans to enroll 50 participants.