Colostomy
Conditions
Brief summary
The study evaluates the efficacy of a new 2-piece appliance in patients with colostomy.
Interventions
DEVICEAOS-C2000-B
1 base plate for 2 or 3 days and 1 to 4 collection special pouch per day
Sponsors
BBraun Medical SAS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is at least 18 years old * Patient having a colostomy with a diameter less than 30 mm for users of Ø 55 mm pouches or having a colostomy with a diameter less than 40 mm for users of Ø 65 mm pouches * Patient having a colostomy for at least 1 month * Patient using currently the two-piece flat ostomy appliance Flexima®/Softima® 3S for at least 2 weeks and being satisfied * Patient having a stoma protusion smaller than or equal to 1.5 cm * Patient capable to apply and remove the appliance himself or with the help of a caregiver (except health care professional) * Patient having a mental capacity to participate to the study (i.e. to understand the study and to answer to the questions) * Patient agreeing to test the new appliance during the training phase (5±3 days) and during the study device usage phase (14±3 days) * Patient covered by social security
Exclusion criteria
* Patient experiencing repeated leakages with the usual pouching system * Patient currently suffering from peristomal skin complications (bleeding or red and broken skin at the time of inclusion) * Patient receiving or having received, within the last month, chemotherapy, radiotherapy or corticotherapy * Patient already participating in another clinical study or who have previously participated in this investigation * Pregnant or breast-feeding woman
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Description of efficacy in term of type of bag deployment and leakage prevention | At least 1 time per day during 14±3 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ease of bag deployment | 14±3 days | Evaluation with a questionnaire (4-points very satisfying to not at all satisfying) |
| Peristomal skin evaluation with DET score scale | baseline and 5±3 days and 14±3 days | — |
| Ease of special bag handling | 14±3 days | Evaluation with a questionnaire (4-points very satisfying to not at all satisfying) |
| Investigational product bag ease of use of gas release button | 14±3 days | Evaluation with a questionnaire (4-points very satisfying to not at all satisfying) |
| Ease of control of gas release button | 14±3 days | Evaluation with a questionnaire (4-points very satisfying to not at all satisfying) |
| General impression about the investigational device before use | 14±3 days | Evaluation with a questionnaire (4-points very satisfying to not at all satisfying) |
| Investigational device wearing comfort | 14±3 days | Evaluation with a questionnaire (4-points very satisfying to not at all satisfying) |
| Investigational device flexibility | 14±3 days | Evaluation with a questionnaire (4-points very satisfying to not at all satisfying) |
| Investigational device discretion | 14±3 days | Evaluation with a questionnaire (4-points very satisfying to not at all satisfying) |
| Ease of base plate handling | 14±3 days | Evaluation with a questionnaire (4-points very satisfying to not at all satisfying) |
| Investigational device adhesivity during wear time | 14±3 days | Evaluation with a questionnaire (4-points very satisfying to not at all satisfying) |
| Investigational device filter performance with deployed bag | 14±3 days | Evaluation with a questionnaire (4-points very satisfying to not at all satisfying) |
| Investigational device filter performance with undeployed bag | 14±3 days | Evaluation with a questionnaire (4-points very satisfying to not at all satisfying) |
| Investigational product bag deployment reason | At each bag change during 14±3 days | Evaluation with a questionnaire (4-points very satisfying to not at all satisfying) |
| Noise during Investigational device wear time | 14±3 days | Evaluation with a questionnaire (4-points very satisfying to not at all satisfying) |
| 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 | 14±3 days | (4-points very satisfying to not at all satisfying) |
| 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 | At each bag change during 14±3 days | Choice between some accessories |
| 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 | — |
| Efficacy of Investigational device gas release button | 14±3 days | Evaluation with a questionnaire (4-points very satisfying to not at all satisfying) |
Countries
France
Outcome results
None listed