Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study evaluates the performance of a new 1-piece ostomy convex appliance in patients with enterostomy.
Primary outcome Measure:
To describe Investigational Device performance in term of level of leakage under the skin protector
Secondary Outcome Measure:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flexima Active Soft convexe | Experimental | Flexima Active soft convexe (1 to 3 appliances per day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flexima Active soft convexe | Device | The Investigational Device will be used during 14 +- 3 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Flexima® Active Soft Convex ostomy appliance performance description in term of level of leakage under the skin protector | 14 +- 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Peristomal skin evaluation with DET score scale | baseline and 14 +- 3 days | |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | baseline and 14 +- 3 days | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Patrick RAT, MD | University Hospital of Dijon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Patrick RAT | Dijon | 21000 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Investigational product wear time |
The patient will complete his patient diary after each Investigational Product removal |
| 14 +- 3 days |
| Investigational product adhesivity as measured by a Likert scale score (1-4) | 14 +- 3 days |
| Investigational product flexibility as measured by a Likert scale score (1-4) | 14 +- 3 days |
| Investigational product conformability as measured by a Likert scale score (1-4) | 14 +- 3 days |
| Convex ring suppleness of the Investigational product as measured by a Likert scale score (1-4) | 14 +- 3 days |
| Connection of the Investigational Product belt to the belt hear as measured by a Likert scale score (1-4) | 14 +- 3 days |
| Residues on the skin after each Investigational Product removal as measured by a Likert scale score (1-4) | 14 +- 3 days |
| Ease of Investigational Product handling as measured by a Likert scale score (1-4) | 14 +- 3 days |
| Investigational Product wearing comfort as measured by a Likert scale score (1-4) | 14 +- 3 days |
| Investigational Product leakage prevention as measured by a Likert scale score (1-4) | 14 +- 3 days |
| Feeling of Investigational Product security as measured by a Likert scale score (1-4) | 14 +- 3 days |
| Investigational Product overall satisfaction as measured by a Likert scale score (1-4) | 14 +- 3 days |
| Use of Investigational Product in the future as measured by a Likert scale score (1-2) | 14 +- 3 days |