Trials / Completed
CompletedNCT02176954
The Influence of Adhesive Wafer Design on Fit to the Body
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Coloplast A/S · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this study is to investigate the influence of the adhesive wafer design on the products ability to fit to the body..
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Test A | Test A is a new 1-piece ostomy appliance developed by Coloplast A/S |
| DEVICE | Test B | Test B is a new 1-piece ostomy appliance developed by Coloplast A/S |
| DEVICE | Comparator | Two comparators will be used: Moderma Flex (Hollister) or Confidence Natural drainable (Salts).These product are commercially available. Subjects will be randomized into one of twelwe arms. Data will be analyzed by pooling the two comparators, Moderma Flex and Confidence Natural, Drainable, why six arms are displayed. |
Timeline
- Start date
- 2014-07-01
- Primary completion
- 2015-02-01
- Completion
- 2015-03-01
- First posted
- 2014-06-27
- Last updated
- 2015-03-23
Locations
10 sites across 2 countries: Netherlands, United Kingdom
Source: ClinicalTrials.gov record NCT02176954. Inclusion in this directory is not an endorsement.