Randomized Controlled Multicenter Study to Evaluate the Performance of Flexima® Active vs. Sensura® in Patients With Colostomy
NCT02223104 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70
Last updated 2015-07-31
Summary
The purpose of this study is to demonstrate that the performance of Flexima Active is non-inferior to the performance of Sensura.
Conditions
- Colostomy
Interventions
- DEVICE
-
Flexima Active
- DEVICE
-
Sensura
Sponsors & Collaborators
-
BBraun Medical SAS
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-10-31
- Primary Completion
- 2014-10-31
- Completion
- 2014-10-31
Countries
- France
Study Locations
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