Multicenter and Open Pilot Clinical Study on the Safety of a New One-piece Convex Appliance in Patients With Enterostomy

Study Overview
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Brief Summary
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This study evaluates the performance of a new 1-piece ostomy convex appliance in patients with enterostomy.

Detailed Description
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Primary outcome Measure: To describe Investigational Device performance in term of level of leakage under the skin protector Secondary Outcome Measure: Assessment of the condition of peristomal skin Assessment of other performance criteria Assessment of AEs for each patient

Official Title
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Multicenter and Open Pilot Clinical Study on the Safety of a New One-piece Convex Appliance in Patients With Enterostomy

Conditions
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Enterostomy

Intervention / Treatment
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* Device: Flexima Active soft convexe


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 or an ileostomy for at least 1 month, patient having a stoma's diameter inferior to 45 mm, patient having a flat or flushed or slightly retracted stoma, patient using currently a one-piece soft convex or standard ostomy appliance with closed or drainable bags, patient using a minimum of 1 product per day with closed pouches or minimum 1 product per two days with drainable pouches patient capable to apply and remove the pouch 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 investigational product during 14(±3) days. patient covered by social security Exclusion Criteria: patient experiencing repeated leakages with his current appliance, patient receiving or having received, within the last month, chemotherapy or radiotherapy or corticotherapy, patient having a deeply retracted stoma, patient currently suffering from peristomal skin complications (bleeding or severe irritation or red and broken skin at the time of inclusion), 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flexima Active Soft convexe<br>Flexima Active soft convexe (1 to 3 appliances per day) | Device: Flexima Active soft convexe<br>* The Investigational Device will be used during 14 +- 3 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |