Investigating the Safety and Performance of SenSura Test Product in Subjects With Ileostomy

Study Overview
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Brief Summary
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The aim of the current Investigation is to evaluate the safety and performance of SenSura test product 1pc flat and convex light compared with commercial SenSura.

Detailed Description
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Investigators want to measure degree of leakage on a 4-point scale of SenSura and SenSura test product.

Official Title
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Investigating the Safety and Performance of SenSura Test Product in Subjects With Ileostomy

Conditions
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Stoma Ileostomy

Intervention / Treatment
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* Device: SenSura
* Device: SenSura test product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have given written informed consent Be at least 18 years of age and have full legal capacity Be able to handle the products themselves Have an ileostomy (end or loop ostomy) with a diameter between 10 - 40 mm Have had their ileostomy for at least 3 months Have used a 1-piece flat or convex light ostomy appliance with an open bag within the last month Currently using midi or maxi bags Willing to use minimum 1 product every second day (max. 2 days wear time) Be mentally and physically capable of understanding and following the study procedures and completing the Case Report Form Must be able to cut products themselves Exclusion Criteria: Currently receiving or have received within the past 2 months chemo- or/and radiation therapy Currently receiving or have received within the past month local or systemic steroid treatment in the peristomal area Are pregnant or breastfeeding Participating in other interventional clinical investigations or have previously participated in this investigation Currently suffering from peristomal skin problems (i.e. bleeding or broken skin). Known hypersensitivity of the product components and/or ingredients

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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SenSura test product 1pc<br>Subjects randomized to treatment sequence 1test: SenSura test product SenSura | Device: SenSura<br>* SenSura is a Commercial and CE-marked ostomy product (1pc) manufactured by Coloplast A/S<br>Device: SenSura test product<br>* SenSura test product is a CE-marked ostomy product (1pc) manufactured by Coloplast A/S<br>|
| Experimental: SenSura 1pc<br>Subjects randomized to treatment sequence 2 test: SenSura SunSura test product | Device: SenSura<br>* SenSura is a Commercial and CE-marked ostomy product (1pc) manufactured by Coloplast A/S<br>Device: SenSura test product<br>* SenSura test product is a CE-marked ostomy product (1pc) manufactured by Coloplast A/S<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of leakage | Leakage under and outside the baseplate will be assessed by a 4 point leakage scale. | patients will test the products for 4 weeks |