Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06631313
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-03
Brief Title:
PureWick Adolescent Study
Sponsor:
None
Organization:
None
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None