Trials / Terminated
TerminatedNCT04703413
User Satisfaction When Catheterizing With Hydrophilic Urinary Catheters From a More Sustainable Manufacturing Process.
User Satisfaction When Catheterizing With Hydrophilic Urinary Catheters From a More Sustainable Manufacturing Process. An Open, Prospective, Post-market Clinical Follow-up Investigation.
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Wellspect HealthCare · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
An open, prospective, single arm, multicenter clinical investigation. All subjects will use the investigational device for 30 days each.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | LoFric® OrigoTM and LoFric® SenseTM | The investigational device is either a CE-marked LoFric® OrigoTM , 40 cm, CH12/CH14 or LoFric® SenseTM, 15 cm, CH12. They are all intermittent urinary catheters with a Nelaton tip from a more sustainable manufacturing process. All subjects will use the investigational device for 30 days each. |
Timeline
- Start date
- 2020-12-17
- Primary completion
- 2023-04-15
- Completion
- 2023-04-15
- First posted
- 2021-01-11
- Last updated
- 2023-04-28
Locations
3 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT04703413. Inclusion in this directory is not an endorsement.