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New catheter design tested in teens for better urine capture

NCT ID NCT06631313

Knowledge-focused Sponsor: C. R. Bard 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how well two external catheter devices (PureWick for males and PureWick Flex for females) collect urine in healthy teenagers aged 12 to 21. Researchers measured the amount of urine captured and how comfortable the devices felt. The goal was to see if these catheters work well for adolescents.

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

43 people

The number who actually took part.

Started

Aug 2024

Finished

Sep 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

12 to 21 years

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: 1. Healthy Adolescent Male or Female aged 12 through 21 years old 2. Able to independently and voluntarily void urine 3. Ability to speak and understand English. 4. Willing to comply with all study procedures in the protocol. 5. Provision of signed and dated informed consent form. Exclusion Criteria: 1. Has urinary retention 2. Incontinent to feces 3. Has any irritation, wound, open lesion at the device application site. 4. For females: currently menstruating without use of an internal device, e.g. tampon or menstrual cup, during the execution of the study. 5. For females: currently pregnant at time of consenting (self-reported) 6. Currently enrolled in or has previously been enrolled in or has completed nursing or other clinical training and courses. 7. Has ever been employed as a home health aide or homecare provider. 8. Any other condition that, in the opinion of the investigator, would preclude them from participating in the study.

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As listed by the trial registrant

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

Healthy volunteers, adolescent

Contacts and locations

Locations

  • TKL Research, Inc.

    Fair Lawn, New Jersey, 07410, United States