Compliance, Patient Clinical Trial
Official title:
Explorative Clinical Study Investigating the Performance and Acceptance of New Intermittent Catheters in Healthy Volunteers
Performance and acceptance of new intermittent catheters tested in healthy volunteers
This study is a single blinded, randomised, crossover study. The study period consists of an
information visit, an inclusion visit, three test visits and a termination visit.
Two prototypes of intermittent catheters (Test product 2 and 3) compared to the standard
catheter SpeediCath® Flex (Comparator).
In the investigation ten subjects will be included. The subjects will be catheterised once
per visit. The subjects will be catheterised with the two test catheters and comparator in a
randomised order. The order of the catheterisations will be randomised to prevent bias.
During the test visits the primary, secondary and explorative endpoints will be registered.
Subjects will be asked to participate in an interview in continuation of their last visit
(Test Visit 3). The interviews will be performed by a Coloplast representative asking
questions related to their experience with the catheter.
The subjects must sign a separate consent form for this purpose and can participate in the
investigation without participating in the interview. In addition, subjects will be asked for
consent to tape recording and filming during the interviews, but can participate in
interviews without this.
In addition, a Coloplast representative will interview the Investigator and her
representatives after LPO with questions related to their experience with the catheters.
The investigation is planned to be conducted in August 2018-Januar 2019. The visit window
will be minimum five days between the visits (catheterisations), to ensure time for healing
of any potential urethral trauma. However, the maximum time between visits should be adjusted
to ensure the subject is terminated before LPO.
No biobank will be established for this investigation. All urine samples in the clinical
investigation (for evaluating in- and exclusion criteria and for evaluating end points) will
be destructed immediately after analysis.
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