Trials / Completed
CompletedNCT03684941
Evaluation of a New Catheter Coating Process for Urinary Catheters Used for Intermittent Catheterization.
Evaluation of a New Catheter Coating Process for Urinary Catheters Used for Intermittent Catheterization - A Prospective, Blinded, Randomized, Cross-over, Multicenter Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Dentsply International · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, double-blinded, randomized, multi-centre, cross-over study. All subjects will use both the study device (test catheter) and the comparator (control catheter) for one week each.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Treatment Period One | LoFric Origo urinary catheter, 40-cm length, CH12/CH14 diameter, with Nelaton tip |
| DEVICE | Treatment Period Two | CE-marked LoFric Origo urinary catheter, 40-cm length, CH12/CH14 diameter, with Nelaton tip |
Timeline
- Start date
- 2018-08-29
- Primary completion
- 2018-11-19
- Completion
- 2018-11-19
- First posted
- 2018-09-26
- Last updated
- 2018-12-05
Locations
8 sites across 1 country: Sweden
Source: ClinicalTrials.gov record NCT03684941. Inclusion in this directory is not an endorsement.