Trials / Completed
CompletedNCT01799239
Safety and Performance of Newly Developed 1-piece Ostomy Product Compared With SenSura
Investigating the Safety and Performance of Newly Developed 1-piece Ostomy Product Concept Compared With SenSura 1-piece in Subjects With an Ileostomy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Coloplast A/S · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The aim of the current investigation is to evaluate the combination of an adhesive with a soft top film.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Test product | The test product consists of an adhesive with a new top film |
| DEVICE | SenSura | SenSura is the CE-marked and commercially available comparator product |
Timeline
- Start date
- 2013-02-01
- Primary completion
- 2013-03-01
- Completion
- 2013-03-01
- First posted
- 2013-02-26
- Last updated
- 2016-09-30
- Results posted
- 2013-12-05
Locations
1 site across 1 country: Sweden
Source: ClinicalTrials.gov record NCT01799239. Inclusion in this directory is not an endorsement.