Clinical Trial of New Intermittent Single-use Catheter

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2023
A multi-centre, open-labelled, randomised, crossover design. The total study duration for the individual subject will be approximately 4 weeks, consisting of four site visits and two 2-week test periods at home. Visits 0 and 1 can be performed on the same day. For visit 2 and 3, 2 catheterisations will be performed in a hospital setting (one HCP catheterisation and one self-catheterisation) for bladder emptying and user experience assessments. Visit 1 and 2 are followed by a home-use test period, followed by visit 3 which terminates the study.
Epistemonikos ID: e9c04943c11cdf752ade40d824cd5d5c6cda32a6
First added on: Feb 19, 2024