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New skin device could replace nuclear scan for shunt checks

NCT ID NCT04309487

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares a device called ShuntCheck, which uses heat to measure fluid flow through a shunt, to the standard nuclear medicine test for detecting blockages. Researchers will enroll 20 adults aged 40 and older with normal pressure hydrocephalus who have a shunt and are suspected of having a blockage. The goal is to see if ShuntCheck is accurate enough to replace the more complex radionuclide test.

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 quicker, radiation-free way to check if a shunt is blocked in patients with normal pressure hydrocephalus.
What could go wrong
This is a small, early study with only 20 participants, so results may not apply to everyone. The device may not be as accurate as the standard test.

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

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2020

Expected to finish

Jan 2027

An estimate. End dates often move.

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 NPH hydrocephalus research subjects who have a VP shunt with a single ventricular catheter implanted for adult hydrocephalus are suspected of shunt obstruction and are scheduled for a radionuclide SPS.

Ages

40 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: * Men or women 40 yo or older and have a VP shunt placed for NPH and are suspected of shunt obstruction. * 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 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.

normal pressure hydrocephalus

As listed by the trial registrant

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

Hydrocephalus, normal pressure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    RECRUITING

    Tampa, Florida, 33606, United States

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