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Ultrasound gadget on catheters aims to cut infections and boost comfort

NCT ID NCT06319352

Symptom relief Sponsor: University of Michigan Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time

Summary

This pilot study tests whether a device called UroShield, which sends gentle ultrasound waves through a urinary catheter tube, can improve quality of life and reduce infections for long-term care residents who need a catheter. About 18 adults with an indwelling catheter will be randomly assigned to receive either an active or a sham (inactive) device. The main goal is to see if a larger study is practical, not yet to prove the device works.

What this could mean

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

Active substance
a small ultrasound device called UroShield that attaches to the urinary catheter tube
What this could lead to
If it works, this could offer a drug-free way to reduce catheter-related discomfort and infections for people in long-term care.
What could go wrong
This is a very small pilot study focused on feasibility, not effectiveness. The device may not improve quality of life or prevent infections in a larger trial.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

18 people

The number who actually took part.

Started

Apr 2024

Finished

Nov 2024

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Male or female age 18+ * Indwelling urinary catheter (urethral or suprapubic) in place * Written informed consent (and assent, when applicable) obtained from participant or participant's legal representative * Able to comply with the requirements of the study Exclusion Criteria: * Pregnant or breastfeeding women * Antibiotic use in past 10 days * Ineligible catheter type in place (e.g., antimicrobial coated, 3-way catheter, condom catheter, nephrostomy tube, wicking device) * Participation in another drug or device study in past 30 days * History of poor compliance to medical treatment regimens * Conditions that may severely compromise their ability to complete the study

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As listed by the trial registrant

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

Catheter-associated urinary tract infection Quality of life

Contacts and locations

Locations

  • Evangelical Home - Saline

    Saline, Michigan, 48176, United States

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