Trials / Completed
CompletedNCT01994902
Investigation of Newly Developed Ostomy Products in Subjects With Ileostomy
Investigation of Newly Developed 1-and 2-piece Convex Ostomy Products in Subjects With Ileostomy.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 129 (actual)
- Sponsor
- Coloplast A/S · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The aim of the investigation was to investigate the performance and safety of a new ostomy product.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Coloplast test product | The Coloplast test product is a newly developed ostomy appliance |
| DEVICE | SenSura Convex Light | The comparator product is SenSura Convex Light, which is CE-marked and commercially available. |
Timeline
- Start date
- 2013-11-01
- Primary completion
- 2014-06-01
- Completion
- 2014-06-01
- First posted
- 2013-11-26
- Last updated
- 2016-01-12
- Results posted
- 2016-01-12
Locations
29 sites across 5 countries: Denmark, France, Germany, Norway, United Kingdom
Source: ClinicalTrials.gov record NCT01994902. Inclusion in this directory is not an endorsement.