Trials / Completed
CompletedNCT01957553
Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared With SenSura Click 2-piece
Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared With SenSura Click in 130 Subjects With an Ileostomy.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 130 (actual)
- Sponsor
- Coloplast A/S · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The aim of the current investigation is to investigate the performance of a new 2-piece ostomy product
Detailed description
The present investigation aims at testing the performance and safety of a new 2-piece ostomy product.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Coloplast test product | Coloplast test product is a newly developed 2-piece ostomy appliance |
| DEVICE | SenSura | SenSura is the commercial available CE-marked SenSura Click 2-piece ostomy appliance from Coloplast A/S |
Timeline
- Start date
- 2013-09-01
- Primary completion
- 2013-12-01
- Completion
- 2013-12-01
- First posted
- 2013-10-08
- Last updated
- 2014-09-08
- Results posted
- 2014-09-08
Locations
17 sites across 5 countries: Belgium, Denmark, Netherlands, Norway, Sweden
Source: ClinicalTrials.gov record NCT01957553. Inclusion in this directory is not an endorsement.