Safety and Performance of New 1-piece Ostomy Product

Study Overview
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Brief Summary
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The aim of the the current investigation is to develop new soft and more flexible 1-piece ostomy products.

Detailed Description
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The present investigation aims at testing the degree of leakage with the new flexible 1-piece ostomy products as well as other performance and safety parameters.

Official Title
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Investigating the Safety and Performance of New 1-piece Ostomy Product Concepts Compared With SenSura 1-piece in Subjects With an Ileostomy

Conditions
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Stoma Ileostomy

Intervention / Treatment
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* Device: Coloplast Adhesive baseplate A
* Device: Coloplast Adhesive baseplate B
* Device: Coloplast Adhesive baseplate C
* Device: SenSura 1-Piece


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 bags themselves. Have an ileostomy with a diameter between 15 and 40 mm. Have had their ostomy for at least three months. Currently use a 1-piece flat ostomy appliance with open bag. Use minimum 1 ostomy appliance every second day. Be suitable for participation in the investigation and for using standard adhesive, flat base plate. Must be able to use a custom cut ostomy appliance. Accept to test three 1-piece ostomy appliances in the investigation. Negative result of a pregnancy test for women of childbearing age (only DK). 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 months 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. Currently using ostomy belt. Currently using extended wear product. 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 |
| --- | --- |
| Experimental: Treatment sequence 1<br>The subjects randomised to Treatment sequence 1 are going to test Coloplast Adhesive baseplate A (A) Coloplast Adhesive baseplate B (B) SenSura 1-piece (S) The subjects test the three test products in a randomised order: ABS; BSA; SAB | Device: Coloplast Adhesive baseplate A<br>* Coloplast Adhesive baseplate A is a newly developed 1-piece ostomy appliance.<br>Device: Coloplast Adhesive baseplate B<br>* Coloplast Adhesive baseplate B is a newly developed 1-piece ostomy appliance<br>Device: SenSura 1-Piece<br>* SenSura 1-piece is the commercial CE-marked Coloplast 1-piece SenSura .<br>|
| Experimental: Treatment sequence 2<br>The subjects randomised to Treatment sequence 2 are going to test Coloplast Adhesive baseplate B (B) Coloplast Adhesive baseplate C (C) SenSura 1-piece (S) The subjects test the three test products in a randomised order: CBS; BSC; SCB | Device: Coloplast Adhesive baseplate B<br>* Coloplast Adhesive baseplate B is a newly developed 1-piece ostomy appliance<br>Device: Coloplast Adhesive baseplate C<br>* Coloplast Adhesive baseplate C is a newly developed 1-piece ostomy appliance<br>Device: SenSura 1-Piece<br>* SenSura 1-piece is the commercial CE-marked Coloplast 1-piece SenSura .<br>|
| Experimental: Treatment sequence 3<br>The subjects randomised to Treatment sequence 3 are going to test Coloplast Adhesive baseplate A (A) Coloplast Adhesive baseplate B (C) SenSura 1-piece (S) The subjects test the three test products in a randomised order: ACS; CSA; SAC | Device: Coloplast Adhesive baseplate A<br>* Coloplast Adhesive baseplate A is a newly developed 1-piece ostomy appliance.<br>Device: Coloplast Adhesive baseplate C<br>* Coloplast Adhesive baseplate C is a newly developed 1-piece ostomy appliance<br>Device: SenSura 1-Piece<br>* SenSura 1-piece is the commercial CE-marked Coloplast 1-piece SenSura .<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 measured using a 4-point leakage scale developed by Coloplast A/S at every baseplate change. The subjects had to tick off one of the following choices: No leakage Starting to leak Leakage Sudden Leakage | one week | 

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