Status:
COMPLETED
Investigation of New Intermittent Catheters in Healthy Volunteers
Lead Sponsor:
Coloplast A/S
Conditions:
Retention, Urinary
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Investigation of non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters with a comparator catheter in 30 adult healthy v...
Detailed Description
The CP322 study investigated a novel non-CE marked intermittent catheter for males and females, designed in two different variants, Variant 1 and Variant 2, respectively. The study was conducted in De...
Eligibility Criteria
Inclusion
- Minimum 18 years of age and with full legal capacity
- Written informed consent and signed letter of authority and secrecy agreement given
- Willing to comply with not using analgesics 1 up to 24 hours prior to catheterization visits
- Urine Multistix negative for erythrocytes (hematuria)
Exclusion
- Participation in any other clinical investigations during this investigation
- Known hypersensitivity towards any of the test products
- Symptoms of urinary tract infection (UTI) (Investigators judgement)
- Pregnancy or breastfeeding
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04445051
Start Date
March 1 2020
End Date
September 1 2020
Last Update
July 3 2023
Active Locations (1)
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1
Urologisk klinik, Afsnit 2112, Rigshospitalet
Copenhagen, Copenhagen Ø, Denmark, 2100