CP348: Clinical trial of a new intermittent single-use catheter
Research type
Research Study
Full title
CP348 - A randomized, open-labelled, crossover study confirming performance of a new single-use compact intermittent catheter in a population of adult female intermittent catheter users.
IRAS ID
327079
Contact name
Nikesh Thiruchevlam
Contact email
Sponsor organisation
Coloplast A/S
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
Coloplast is in the process of developing a new intermittent catheter for females.
The aim of this investigation is to demonstrate superiority of the new catheter and to assess safety and perception.
The investigation will be conducted from June 2023 to Dec 2023, enrolling 72 subjects in Denmark, France and UK. In the UK we expect up to 4 clinic sites in total. Once enrolled the subjects will be in the study approximately 4 weeks and required
to attend upto 4 visits at the clinic. At the first and second visit, the participants will be given either the new catheter test product or one of two comparator catheter products to use at home for two weeks. The two comparator catheter products are already on the market in the UK. The order that the catheters are tested are randomly assigned. Self catheterisation and catheterisation by a HCP will be required at some study visits and urine flow-stops and urine volume will be measured. There will also be questionnaires to answer about the new test catheter.REC name
HSC REC A
REC reference
23/NI/0056
Date of REC Opinion
2 Jun 2023
REC opinion
Further Information Favourable Opinion