Trials / Completed
CompletedNCT05644912
Exploratory Investigation on a Novel Catheter
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- Wellspect HealthCare · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
An exploratory, pre-market, open, prospective, interventional, clinical investigation at a limited number of centers for proof of concept of a new catheter. In this proof of concept investigation, subjects experienced in using transanal irrigation (TAI) with a balloon catheter will be using study catheters at two occasions to primarily study if the catheter will stay in place during the water instillation when performing TAI. Each subject will be followed during approximately one week, depending on the usual time between their TAI.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Transanal irrigation (TAI) | Transanal irrigation (TAI) with new catheter on subjects experienced in using TAI with balloon catheter. |
Timeline
- Start date
- 2022-11-18
- Primary completion
- 2023-12-15
- Completion
- 2023-12-15
- First posted
- 2022-12-09
- Last updated
- 2024-04-24
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT05644912. Inclusion in this directory is not an endorsement.