Healthy Volunteers, AdolescentNCT06631313
PureWick™ Adolescent Study
A study testing PureWick System in people with Healthy Volunteers, Adolescent, run by C. R. Bard at 1 site in United States.
Trial summary
A prospective, uncontrolled, open-label healthy volunteer study to assess the performance of the PureWick Male and PureWick Flex Female external catheter devices in adolescents Read more about this study
- Who is it for?
- Ages 12 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Adolescent
- What is being tested?
- PureWick System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2024to 25 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy Adolescent Male or Female aged 12 through 21 years old
- Able to independently and voluntarily void urine
- Ability to speak and understand English.
- Willing to comply with all study procedures in the protocol.
- Provision of signed and dated informed consent form.
Who cannot join
- Has urinary retention
- Incontinent to feces
- Has any irritation, wound, open lesion at the device application site.
- For females: currently menstruating without use of an internal device, e.g. tampon or menstrual cup, during the execution of the study.
- For females: currently pregnant at time of consenting (self-reported)
- Currently enrolled in or has previously been enrolled in or has completed nursing or other clinical training and courses.
- Has ever been employed as a home health aide or homecare provider.
- Any other condition that, in the opinion of the investigator, would preclude them from participating in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Uncontrolled, Open-label Healthy Volunteer Study to Assess the Performance of the PureWick™ Male and PureWick™ Flex Female External Catheter Devices in Adolescents
A prospective, uncontrolled, open-label healthy volunteer study to assess the performance of the PureWick Male and PureWick Flex Female external catheter devices in adolescents
Read the detailed description
The objective of this healthy volunteer study is to understand if external catheters are an effective alternative in the adolescent population in both male and female adolescents. The main question it aims to answer is: Do the PureWick Male and PureWick Flex female external catheters effectively capture urine in the adolescent population after both healthcare professional placement and self-placement? Participants will void while wearing the external catheter two times and answer brief questionnaires assessing perceived wetness, IFU comprehension, comfort and ease of use. Total study participation time is 2-3 hours in a single day.
- Conditions
- Healthy Volunteers, Adolescent
- Being tested
- PureWick System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PureWick SystemDevice
The PureWick System consists of the PureWick Urine Collection System used with either the PureWick Male External Catheter or the PureWick Flex Female External Catheter, which are intended for non-invasive urine output management.
| Study group | Role | What they receive |
|---|---|---|
| PureWick System | Experimental | Not described Receives: Device: PureWick System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of the PureWick System in Adolescents After HCP Placement and Self-placement
Capture rate following void (captured as % of urine captured by device and collected in canister, measured by weight).
Prior to each void, the weight of the empty urine collection canister and the weight of a dry absorbent pad are collected. Participants void into the device while laying in a bed with the absorbent pad underneath them. After each void, the post-void weight of the urine collection canister and the post-void weight of the absorbent pad are collected.
Capture rate is calculated as the weight of captured urine (post-void canister weight - pre-void canister weight) / total urine volume (captured urine (post-void canister weight - pre-void canister weight) + leaked urine (post-void pad weight - pre-void pad weight)) * 100.
Measured: Approximately 2 hours after device placement
Secondary outcomes (4)
Participant Comfort
Overall comfort on a 5-point Likert scale ranging from 1- 5 with higher scores indicating a better outcome, where 1 = Very Uncomfortable, 2 = Uncomfortable, 3 = Neither Comfortable or Uncomfortable, 4 = Comfortable, and 5 = Very Comfortable.
The last survey question related to likelihood to recommend the device ranged from 1-5 with higher scores indicating a better outcome, where 1 = Very Unlikely, 2 = Unlikely, 3 = Neither Likely Nor Unlikely, 4 - Likely, and 5 = Very Likely.
Measured: Approximately 2 hours after device placement
Participant Ease of Use
Ease of use score on a 5-point Likert scale ranging from 1- 5 with higher scores indicating a better outcome, where 1 = Very Difficult, 2 = Somewhat Difficult, 3 = Average Difficulty, 4 = Somewhat Easy
Measured: Approximately 2 hours after device placement
IFU Comprehension
Overall IFU comprehension on a 5-point Likert scale ranging from 1- 5 with higher scores indicating a better outcome, where 1 = Strongly Disagree, 2 = Disagree, 3 = Neutral, 4 = Agree, and 5 = Strongly Agree.
Measured: Approximately 2 hours after device placement
HCP Ease of Use
Ease of use score on a 5-point Likert scale ranging from 1- 5 with higher scores indicating a better outcome, where 1 = Very Difficult, 2 = Somewhat Difficult, 3 = Average Difficulty, 4 = Somewhat Easy, and 5 = Very Easy.
Measured: From date of first enrollment until the date of last patient completion, approximately 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start28 Aug 2024
- Primary completion10 Sep 2024
- Study completion25 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy Volunteers, AdolescentStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631313
- Sponsor's protocol ID
- UCC-23AC023
- Status last verified
- Sep 2025
- First submitted
- 3 Oct 2024
- Last updated
- 20 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Uncontrolled, Open-label Healthy Volunteer Study to Assess the Performance of the PureWick™ Male and PureWick™ Flex Female External Catheter Devices in Adolescents
- ClinicalTrials.gov ID
- NCT06631313
- Acronym / sponsor ID
- UCC-23AC023
- Conditions
- Healthy Volunteers, Adolescent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- 28 Aug 2024 (actual)
- Primary completion
- 10 Sep 2024 (actual)
- Study completion
- 25 Sep 2024 (actual)
- First posted
- 8 Oct 2024 (actual)
- Results
- Posted 1 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, uncontrolled, open-label healthy volunteer study to assess the performance of the PureWick Male and PureWick Flex Female external catheter devices in adolescents
Detailed description
The objective of this healthy volunteer study is to understand if external catheters are an effective alternative in the adolescent population in both male and female adolescents. The main question it aims to answer is: Do the PureWick Male and PureWick Flex female external catheters effectively capture urine in the adolescent population after both healthcare professional placement and self-placement? Participants will void while wearing the external catheter two times and answer brief questionnaires assessing perceived wetness, IFU comprehension, comfort and ease of use. Total study participation time is 2-3 hours in a single day.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PureWick System | Experimental | Device: PureWick System |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Healthy Adolescent Male or Female aged 12 through 21 years old
- Able to independently and voluntarily void urine
- Ability to speak and understand English.
- Willing to comply with all study procedures in the protocol.
- Provision of signed and dated informed consent form.
Key exclusion criteria (8 listed)
- Has urinary retention
- Incontinent to feces
- Has any irritation, wound, open lesion at the device application site.
- For females: currently menstruating without use of an internal device, e.g. tampon or menstrual cup, during the execution of the study.
- For females: currently pregnant at time of consenting (self-reported)
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 |
|---|---|---|
| PureWick SystemThe PureWick System consists of the PureWick Urine Collection System used with either the PureWick Male External Catheter or the PureWick Flex Female External Catheter, which are intended for non-invasive urine output management. | Device | PureWick System |
Primary outcome
Performance of the PureWick System in Adolescents After HCP Placement and Self-placement
Time frame: Approximately 2 hours after device placement
Capture rate following void (captured as % of urine captured by device and collected in canister, measured by weight). Prior to each void, the weight of the empty urine collection canister and the weight of a dry absorbent pad are collected. Participants void into the device while laying in a bed with the absorbent pad underneath them. After each void, the post-void weight of the urine collection canister and the post-void weight of the absorbent pad are collected. Capture rate is calculated as the weight of captured urine (post-void canister weight - pre-void canister weight) / total urine volume (captured urine (post-void canister weight - pre-void canister weight) + leaked urine (post-void pad weight - pre-void pad weight)) * 100.
4 secondary outcomes
Participant Comfort
Time frame: Approximately 2 hours after device placement
Participant Ease of Use
Time frame: Approximately 2 hours after device placement
IFU Comprehension
Time frame: Approximately 2 hours after device placement
HCP Ease of Use
Time frame: From date of first enrollment until the date of last patient completion, approximately 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PureWick System in people with Healthy Volunteers, Adolescent, run by C. R. Bard 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 5 inclusion and 8 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 20 Oct 2025. 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?
Yes. Results are posted in the registry (first posted 1 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Performance of the PureWick System in Adolescents After HCP Placement and Self-placement (time frame: Approximately 2 hours after device placement). 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 20 Oct 2025.