Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2015-A00611-48 | Other Identifier | FRENCH HEALTH AUTORITY |
Not provided
Not provided
Not provided
Investigational product needs improvements
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
The study evaluates the efficacy of a new 2-piece appliance in patients with colostomy.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AOS-C2000-B | Experimental | A new 2-piece appliance composed with 2 parts : a base plate and an ostomy collection special pouch (1 base plate for 2 or 3 days and 1 to 4 collection special pouch per day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AOS-C2000-B | Device | 1 base plate for 2 or 3 days and 1 to 4 collection special pouch per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Description of efficacy in term of type of bag deployment and leakage prevention | After each change of the investigational product, the patient will describe on a 3-point scale the type of deployment "manual", "spontaneous - in link with stools or gas", "spontaneous - no link with stools or gas" | At least 1 time per day during 14±3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Peristomal skin evaluation with DET score scale | baseline and 5±3 days and 14±3 days | |
| Investigational product bag deployment reason | Evaluation with a questionnaire (4-points very satisfying to not at all satisfying) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mahaut LECONTE, MD | University Hospital of Paris - Cochin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Georges François Leclerc | Dijon | 21000 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| At each bag change during 14±3 days |
| Ease of bag deployment | Evaluation with a questionnaire (4-points very satisfying to not at all satisfying) | 14±3 days |
| Ease of special bag handling | Evaluation with a questionnaire (4-points very satisfying to not at all satisfying) | 14±3 days |
| Investigational product bag ease of use of gas release button | Evaluation with a questionnaire (4-points very satisfying to not at all satisfying) | 14±3 days |
| Ease of control of gas release button | Evaluation with a questionnaire (4-points very satisfying to not at all satisfying) | 14±3 days |
| General impression about the investigational device before use | Evaluation with a questionnaire (4-points very satisfying to not at all satisfying) | 14±3 days |
| Investigational device wearing comfort | Evaluation with a questionnaire (4-points very satisfying to not at all satisfying) | 14±3 days |
| Investigational device flexibility | Evaluation with a questionnaire (4-points very satisfying to not at all satisfying) | 14±3 days |
| Investigational device discretion | Evaluation with a questionnaire (4-points very satisfying to not at all satisfying) | 14±3 days |
| Ease of base plate handling | Evaluation with a questionnaire (4-points very satisfying to not at all satisfying) | 14±3 days |
| Investigational device adhesivity during wear time | Evaluation with a questionnaire (4-points very satisfying to not at all satisfying) | 14±3 days |
| Investigational device filter performance with deployed bag | Evaluation with a questionnaire (4-points very satisfying to not at all satisfying) | 14±3 days |
| Investigational device filter performance with undeployed bag | Evaluation with a questionnaire (4-points very satisfying to not at all satisfying) | 14±3 days |
| Efficacy of Investigational device gas release button | Evaluation with a questionnaire (4-points very satisfying to not at all satisfying) | 14±3 days |
| Noise during Investigational device wear time | Evaluation with a questionnaire (4-points very satisfying to not at all satisfying) | 14±3 days |
| Overall satisfaction questionnaire of the collection volume of the bag of the Investigational device | 14±3 days |
| Overall security feeling questionnaire with the Investigational device | 14±3 days |
| Overall satisfaction questionnaire with the Investigational device | 14±3 days |
| Overall satisfaction questionnaire regarding bag deployment of the Investigational device | 14±3 days |
| Overall satisfaction questionnaire with cap cover of the Investigational device | 14±3 days |
| General impression about body image during use of the investigational product | (4-points very satisfying to not at all satisfying) | 14±3 days |
| Assessment questionnaire of willingness to use and the frequency of use in the future | 14±3 days |
| Assessment of the investigational device wear time | 14±3 days |
| Assessment questionnaire preference between the investigational device and usual appliance | 14±3 days |
| Assessment of use of accessories | Choice between some accessories | At each bag change during 14±3 days |
| Assessment of the quality of life with Stoma-QoL questionnaire | At baseline, at 5±3 days and 14±3 days |
| Number of participants with Adverse Event as a measure of safety and tolerability | At baseline, at 5±3 days and 14±3 days |