Trials / Completed
CompletedNCT02064231
A Clinical Investigation Examining the Performance and Handling of New 2-piece Ostomy Products in 28 People With an Ileostomy.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- Coloplast A/S · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To assess the functionality and safety of the test products and also assess the products ability to collect stool without interfering with the stoma.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Coloplast Test A | Coloplast Test A is a new ostomy appliance developed by Coloplast A/S |
| DEVICE | Coloplast Test B | Coloplast Test B is a newly developed ostomy appliance developed by Coloplast A/S |
| DEVICE | Own product | Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others. |
| DEVICE | Coloplast Test C | Coloplast Test C is a new ostomy appliance developed by Coloplast A/S |
| DEVICE | Coloplast Test D | Coloplast Test D is a new ostomy appliance developed by Coloplast A/S |
Timeline
- Start date
- 2012-06-01
- Primary completion
- 2012-08-01
- Completion
- 2012-08-01
- First posted
- 2014-02-17
- Last updated
- 2020-09-10
- Results posted
- 2014-04-04
Source: ClinicalTrials.gov record NCT02064231. Inclusion in this directory is not an endorsement.