Trials / Completed
CompletedNCT02362360
Investigation of a New 2-piece Ostomy Product in People With an Ileostomy or Colostomy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 52 (actual)
- Sponsor
- Coloplast A/S · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to investigate the influence of a new ostomy product on the peristomal fit for people with an ileo- or colostomy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Coloplast Test Product | A new 2-piece ostomy appliance developed by Coloplast A/S |
| DEVICE | Comparator (Hollister) | Comparator is a Hollister FlexWear baseplate (ileostomy) or a Hollister SoftFlex baseplate (colostomy) both used with a Hollister open bag. |
Timeline
- Start date
- 2015-02-01
- Primary completion
- 2015-05-01
- Completion
- 2015-05-01
- First posted
- 2015-02-12
- Last updated
- 2016-10-11
- Results posted
- 2016-10-11
Locations
5 sites across 4 countries: Denmark, Germany, Netherlands, Norway
Source: ClinicalTrials.gov record NCT02362360. Inclusion in this directory is not an endorsement.