PureWick™ Adolescent Study

NCT06631313 | Completed Results FDA Device

• 1 other identifier: UCC-23AC023
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Healthy Volunteers, Adolescent

Outcome Measures

Primary Outcomes (1)

• 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.

  Approximately 2 hours after device placement

Secondary Outcomes (4)

• Participant Comfort

  Approximately 2 hours after device placement

• Participant Ease of Use

  Approximately 2 hours after device placement

• IFU Comprehension

  Approximately 2 hours after device placement

• HCP Ease of Use

  From date of first enrollment until the date of last patient completion, approximately 4 weeks

Study Arms (1)

PureWick System

EXPERIMENTAL

Device: PureWick System

Interventions

PureWick System DEVICE

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.

PureWick System

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (1)

TKL Research, Inc.

Fair Lawn, New Jersey, 07410, United States

Location

Results Point of Contact

• Title: Director of Clinical Affairs
• Organization: Becton, Dickinson and Company

kirsten.hammitt@bd.com

551-225-1164

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 8, 2024
• Study Start: August 28, 2024
• Primary Completion: September 10, 2024
• Study Completion: September 25, 2024
• Last Updated: October 20, 2025
• Results First Posted: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)