Trials / Terminated
TerminatedNCT01782196
A Phase II Multi Centre Study to Assess the Safety and Performance of Two Prototype One Piece Pouches in Subjects With an Ileostomy
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- ConvaTec Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Certain research and innovation projects require an assessment of the adhesive properties of adhesives, which cannot be established from in-vitro testing. The most valuable data for assessments of this type comes from adhesion and wear time studies involving application to living human skin on volunteers. The purpose of the study is to assess the safety and performance of an enhanced one piece drainable pouch with a mouldable skin barrier wafer in a group of subjects with an ileostomy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Enhanced one piece drainable pouch with Type A mouldable adhesive | |
| DEVICE | Enhanced one piece drainable pouch with Type B mouldable adhesive |
Timeline
- Start date
- 2012-10-01
- Primary completion
- 2013-03-01
- Completion
- 2013-03-01
- First posted
- 2013-02-01
- Last updated
- 2013-07-03
Locations
5 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT01782196. Inclusion in this directory is not an endorsement.