Trials / Completed
CompletedNCT01995357
The Influence of Baseplate Adhesive on the Degree of Leakage
The Influence of Base Plate Adhesive Type, Shape and Application on Degree of Leak-age - a Randomized Controlled Trial in Subjects With Ileostomy and Colostomy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- Coloplast A/S · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The influence of the baseplate adhesive type, shape and application is investigated with regard to the degree of leakage.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Coloplast Test A | Coloplast Test A is a newly developed ostomy appliance |
| DEVICE | Coloplast Test B | Coloplast Test B is a newly developed ostomy appliance. |
| DEVICE | Standard product | Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation. |
Timeline
- Start date
- 2013-10-01
- Primary completion
- 2013-12-01
- Completion
- 2013-12-01
- First posted
- 2013-11-26
- Last updated
- 2015-02-03
- Results posted
- 2015-02-03
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT01995357. Inclusion in this directory is not an endorsement.