Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-25 @ 6:59 PM
Study NCT ID:
NCT05841004
Status:
COMPLETED
Last Update Posted:
2025-01-23
First Post:
2023-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Clinical Trial of New Single-use Compact Intermittent Catheter
Sponsor:
Coloplast A/S
Organization:
Study Overview
Official Title:
A Randomized, Crossover Study Confirming Performance of a New Single-use Compact Intermittent Catheter vs. Infyna Chic in a Pop-ulation of Adult Female Intermittent Catheter Users.
Status:
COMPLETED
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study is a randomised, single-blinded, controlled crossover study. The total study duration for the individual subject will be between two days - two weeks, consisting of three site visits. Visits 0 and 1 can be performed on the same day. Visit 2 can be performed the day after visit 1. For visit 1 and 2, catheterizations will be performed in a hospital setting by a health care professional for bladder emptying assessment and collection of urine samples for haematuria assessment. A sub-group of subjects (all enrolled subjects at DK sites) will be asked to conduct a self-catheterization at visit 2 after hcp catheterization and evaluate discomfort and PVR.
The total study duration for the individual subject will be up to 14 days.
The total study duration for the individual subject will be up to 14 days.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: