Safety and Performance of New 2-piece Ostomy Product Concept Compared With SenSura Click in Subjects With Ileostomy

Study Overview
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Brief Summary
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The aim of the current clinical investigation is to evaluate the performance and safety of new 2-piece ostomy product concepts.

Detailed Description
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The new products have been developed to reduce the degree of leakage and other problems related to ostomy appliances in people with a stoma.

Official Title
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Investigating the Safety and Performance of New 2-piece Ostomy Product Concept Compared With SenSura Click in Subjects With Ileostomy

Conditions
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Subjects With an Ileostomy

Intervention / Treatment
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* Device: Coloplast A
* Device: Coloplast B
* Device: Coloplast C
* Device: SenSura Click


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have given written informed consent and signed letter of authority form. Be at least 18 years of age and have full legal capacity. Be able to handle the appliances themselves Have an ileostomy with a diameter between 15 and 40 mm. Have had their ostomy for at least three months. Use minimum 1 baseplate every third day. Currently use 2-piece flat mechanical coupling product with open bag and a coupling size in the inter val of 43-55mm (both extremes included) Must be able to use custom cut product Accept to test three 2-piece products within the study. Negative result of a pregnancy test for women of childbearing age. Exclusion Criteria: Use irrigation during the study (flush the stoma with water). Currently receiving or have within the past 2 months received radio- and/or chemotherapy. Currently receiving or have within the past month received 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. More than three days wear time as usual change pattern. Currently using ostomy belt Currently using extended wear product (Sensura Xpro, Assura TERA, Dansac NovaLife X3, Hollister Flextend, Convatec Durahesive) Have a loop ileostomy Known hypersensitivity towards any of the test products Suffer from peristomal skin problems that preclude participation in the investigation (assessed by the investigation nurse)

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment sequence 1<br>Subjects randomised to Treatment sequence 1 will test three different products: Coloplast A Coloplast B SenSura Click The subjects test the three test products in a randomized order: ABS; BSA, SAB | Device: Coloplast A<br>* Coloplast A is a newly developed 2-piece ostomy appliance<br>Device: Coloplast B<br>* Coloplast B is a newly developed 2-piece ostomy appliance<br>Device: SenSura Click<br>* The comparator product is the commercial and CE-marked SenSura Click (2-piece) manufactured by Coloplast A/S.<br>|
| Experimental: Treatment sequence 2<br>Subjects randomised to Treatment sequence 2 will test three different products: Coloplast C (C) Coloplast B (B) SenSura Click (S) The subjects test the three test products in a randomized order: CBS; BSC, SCB | Device: Coloplast B<br>* Coloplast B is a newly developed 2-piece ostomy appliance<br>Device: Coloplast C<br>* Coloplast C is a newly developed 2-piece ostomy appliance<br>Device: SenSura Click<br>* The comparator product is the commercial and CE-marked SenSura Click (2-piece) manufactured by Coloplast A/S.<br>|
| Experimental: Treatment sequence 3<br>Subjects randomised to Treatment sequence 3 will test three different products: Coloplast A (A) Coloplast C (C) SenSura Click (S) The subjects test the three test products in a randomized order: ACS; CSA, SAC | Device: Coloplast A<br>* Coloplast A is a newly developed 2-piece ostomy appliance<br>Device: Coloplast C<br>* Coloplast C is a newly developed 2-piece ostomy appliance<br>Device: SenSura Click<br>* The comparator product is the commercial and CE-marked SenSura Click (2-piece) 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 | The degree of leakage is assessed using a 4 point leakage scale developed by Coloplast A/S. The 4-point leakage scale has four choices No leakage Starting to leakage Leakage Sudden leakage Leakage was assessed at every baseplate change | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stoma ileostomy