Pseudotumor CerebriNCT04309383
ShuntCheck Performance Characteristics in Asymptomatic Pseudotumor Cerebri Patients
An observational study of Pseudotumor Cerebri, run by University of South Florida at 1 site in United States.
Trial 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 pseudotumor cerebri. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pseudotumor Cerebri
- What is being tested?
- ShuntCheck
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2019to 5 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: The study population will consist of asymptomatic PTC research subjects who have a VP shunt with a single ventricular catheter implanted for PTC and are visiting for routine care.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of South Florida Department of Neurological Surgery and Brain Repair
Tampa, Florida, 33606
About this study
Official title: Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Pseudotumor Cerebri
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.
Read the detailed 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
- Conditions
- Pseudotumor Cerebri
- Being tested
- ShuntCheck
- Keywords
- Pseudotumor Cerebri, Ventriculoperitoneal Shunt
- Medical subject headings
- Pseudotumor Cerebri
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShuntCheckDiagnostic test
The intervention is an FDA-cleared device utilizing a transcutaneous thermal convection to analyze shunt flow.
| Study group | Role | What they receive |
|---|---|---|
| ShuntCheck | Participants will be administered the ShuntCheck diagnostic test. Receives: Diagnostic Test: ShuntCheck |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specificity of ShuntCheck test
Measured: 15 minutes
Negative Predictive Value of ShuntCheck test
Measured: 15 minutes
Secondary outcomes (2)
Specificity of performing ShuntCheck test twice
Measured: 60 minutes
Negative Predictive Value of performing ShuntCheck test twice
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start29 Oct 2019
- Primary completion5 Feb 2026
- Study completion5 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pseudotumor CerebriStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- NeuroDx Development
- Responsible party
- Principal investigator, Naomi Abel, University of South Florida
- Investigators
- Naomi Abel, MD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04309383
- Sponsor's protocol ID
- Pro00042422
- Status last verified
- May 2026
- First submitted
- 12 Mar 2020
- Last updated
- 18 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At present there is no plan to share any individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Pseudotumor Cerebri
- ClinicalTrials.gov ID
- NCT04309383
- Acronym / sponsor ID
- Pro00042422
- Conditions
- Pseudotumor Cerebri
- Keywords
- Pseudotumor Cerebri, Ventriculoperitoneal Shunt
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- NeuroDx Development
- Study start
- 29 Oct 2019 (actual)
- Primary completion
- 5 Feb 2026 (actual)
- Study completion
- 5 Feb 2026 (actual)
- First posted
- 16 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ShuntCheck | – | Diagnostic Test: ShuntCheckParticipants will be administered the ShuntCheck diagnostic test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of asymptomatic PTC research subjects who have a VP shunt with a single ventricular catheter implanted for PTC and are visiting for routine care.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ShuntCheckThe intervention is an FDA-cleared device utilizing a transcutaneous thermal convection to analyze shunt flow. | Diagnostic test | ShuntCheck |
Primary outcome
Specificity of ShuntCheck test
Time frame: 15 minutes
Negative Predictive Value of ShuntCheck test
Time frame: 15 minutes
2 secondary outcomes
Specificity of performing ShuntCheck test twice
Time frame: 60 minutes
Negative Predictive Value of performing ShuntCheck test twice
Time frame: 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No. At present there is no plan to share any individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naomi Abel, MD principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pseudotumor Cerebri, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specificity of ShuntCheck test (time frame: 15 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.