Multicenter Pilot Study to Describe the Performance of a New Device in Patients With Colostomy

Study Overview
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Brief Summary
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The study evaluates the efficacy of a new 2-piece appliance in patients with colostomy.

Official Title
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Multicenter Pilot Study to Describe the Performance of a New Device in Patients With Colostomy

Conditions
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Colostomy

Intervention / Treatment
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* Device: AOS-C2000-B


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AOS-C2000-B<br>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) | Device: AOS-C2000-B<br>* 1 base plate for 2 or 3 days and 1 to 4 collection special pouch per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |