Trials / Completed
CompletedNCT01957488
Investigating the Safety and Performance of Two New 1-piece Ostomy Products Compared With SenSura 1-piece
Investigating the Safety and Performance of Two New 1-piece Ostomy Products in 180 Subjects With Ileostomy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 183 (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 two new 1-piece ostomy products
Detailed description
The present investigation aims at testing the performance and safety of the two new 1-piece ostomy products
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Coloplast Test Product 1 | Coloplast Test product 1 is a newly developed 1-piece ostomy appliance |
| DEVICE | Coloplast Test Product 2 | Coloplast Test product 2 is a newly developed 1-piece ostomy appliance |
| DEVICE | Coloplast SenSura | SenSura 1-piece is the commercial available CE-marked SenSura 1-piece from Coloplast A/S. |
Timeline
- Start date
- 2013-07-01
- Primary completion
- 2013-09-01
- Completion
- 2013-09-01
- First posted
- 2013-10-08
- Last updated
- 2020-09-10
- Results posted
- 2014-09-17
Locations
4 sites across 4 countries: Denmark, Netherlands, Norway, United Kingdom
Source: ClinicalTrials.gov record NCT01957488. Inclusion in this directory is not an endorsement.