Multicenter Study to Describe the Performance of the AOS-C2001-B 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 the AOS-C2001-B Device in Patients With Colostomy

Conditions
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Colostomy Stoma

Intervention / Treatment
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* Device: AOS-C2001-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 a flat ostomy appliance 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 evaluation 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-C2001-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-C2001-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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of efficacy in terms of stool collection and leakage prevention | After each change of the investigational product, the patient will describe on a 4-point scale the type of capsule cap cover removal | At least 1 time per day during 14±3 days | 
| Description of efficacy in terms of stool collection and leakage prevention | After each change of the investigational product, the patient will describe on a 4-point scale the level of leakage | At least 1 time per day during 14±3 days |