Trials / Unknown
UnknownNCT03572673
Study to Evaluate the Performance of a New 2-piece Ostomy Appliance vs. Flexima® 3S in Patients With Enterostomy
Randomized Controlled Multicenter Study to Evaluate the Performance of a New 2-piece Ostomy Appliance vs. Flexima® 3S in Patients With Enterostomy
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 38 (estimated)
- Sponsor
- BBraun Medical SAS · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To compare the performance of the comparator Flexima 3S appliance to a new 2-piece appliance in patients with enterostomy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Flexima 3S | Flexima 3S (2-piece appliance) with drainable pouch |
| DEVICE | New 2-piece ostomy appliance | New 2-piece ostomy appliance with drainable pouch |
Timeline
- Start date
- 2018-05-08
- Primary completion
- 2019-04-01
- Completion
- 2019-04-01
- First posted
- 2018-06-28
- Last updated
- 2018-06-28
Locations
2 sites across 1 country: Malaysia
Source: ClinicalTrials.gov record NCT03572673. Inclusion in this directory is not an endorsement.