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Simple skin test may reveal if brain shunts are working

NCT ID NCT04309383

Diagnosis Sponsor: University of South Florida Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a device called ShuntCheck, which uses a mild heat sensor on the skin to see if a brain shunt is flowing properly. Researchers enrolled 12 adults with pseudotumor cerebri who had a shunt placed and were feeling well. The goal was to see if the device could correctly tell when the shunt was working or blocked, without needing X-rays or other tests.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ShuntCheck device
What this could lead to
If successful, this could provide a quick, non-invasive way to check if a shunt is working in pseudotumor cerebri patients, reducing the need for X-rays or scans.
What could go wrong
This was a very small study (12 people) and only looked at asymptomatic patients. The device may not be accurate in all cases or in patients with symptoms.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

12 people

The number who actually took part.

Started

Oct 2019

Finished

Feb 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

pseudotumor cerebri

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pseudotumor cerebri

Contacts and locations

Locations

  • University of South Florida Department of Neurological Surgery and Brain Repair

    Tampa, Florida, 33606, United States

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