Trials / Unknown
UnknownNCT03133585
Study on the Stoma Appliance Flexima®/Softima® 3S
Non-Interventional, International, Post-Marketing Clinical Follow-up Study on the Stoma Appliance Flexima®/Softima® 3S
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,500 (estimated)
- Sponsor
- BBraun Medical SAS · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the satisfaction of patients of the Flexima®/Softima® 3S with 6 months follow-up. The primary variable is to evaluate the degree of satisfaction of patients in terms of leakage prevention, comfort and patient's feeling of security to the Flexima®/Softima® 3S.
Detailed description
The primary variable is to evaluate the degree of satisfaction of patients in terms of leakage prevention, comfort and patient's feeling of security to the Flexima®/Softima® 3S.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 2 piece appliance for stomy | Use of the Flexima®/Softima® 3S during 6 months following the patient's usually frequency of appliance change |
Timeline
- Start date
- 2017-08-23
- Primary completion
- 2021-06-30
- Completion
- 2021-06-30
- First posted
- 2017-04-28
- Last updated
- 2019-04-17
Locations
2 sites across 1 country: France
Source: ClinicalTrials.gov record NCT03133585. Inclusion in this directory is not an endorsement.