NCT06631313

PureWick™ Adolescent Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: C. R. Bard · Industry
• Sex: All
• Age: 12 Years – 21 Years
• Healthy volunteers: Accepted

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

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

Interventions

Type	Name	Description
DEVICE	PureWick System	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.

Timeline

• Start date: 2024-08-28
• Primary completion: 2024-09-10
• Completion: 2024-09-25
• First posted: 2024-10-08
• Last updated: 2025-10-20
• Results posted: 2025-10-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study