A Clinical Investigation Evaluating and Understanding Parameters Affecting the Performance of Ostomy Products

Study Overview
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Brief Summary
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The aim of the study is to obtain an understanding of relevant parameters affecting the performance of ostomy products.

Detailed Description
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72 subjects will be included. Each subject will attend 3 visits at the clinic/hospital or at the subjects home depending on the final site set-up. Each subject will be enrolled for 14 weeks in total for the entire investigation. Coloplast will provide SenSura Mio Convex Soft for all subjects via the investigator. Based on the subjects' usual changing pattern, the investigator will provide the subjects with enough products for the whole test period. The subject will answer questions regarding the tested products by filling out the subject part in the eCRF daily. The subject will answer questions using an electronic device and use the device to take pictures of the peristomal skin and used products at each product change. The Investigator fills out the investigator part of the eCRF at each visit. The subjects must complete the general questions at the end of each test period before their second and third visit at the Clinic/hospital or at home to avoid influence by the investigator. The use of accessories will be noted in the eCRF. Samples of biological material will not be taken or used in this investigation. Patient files from own physician will not be used for subjects recruited via a Coloplast's database. The investigators may use patient files for subjects recruited via hospital sites/ostomy clinics to identifying relevant subjects and/or to verify baseline information, concomitant medication or adverse events. To be able to fulfil the objectives, the investigation must include both ileostomists and colostomists.

Official Title
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A Clinical Investigation Evaluating and Understanding Parameters Affecting the Performance of Ostomy Products

Conditions
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Ileostomy - Stoma, Colostomy

Intervention / Treatment
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* Device: SenSura Mio Convex Soft


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 Have an ileostomy or colostomy Have had their ostomy for at least 3 months Must use 1 piece open or closed ostomy products during the test period Currently using a 1 piece. flat product Must be able to use custom cut product Have intact peristomal skin Has experienced leakage (seeping) under the baseplate at least three times during the last two weeks Are evaluated to be suitable for a soft convex product Exclusion Criteria: Currently receiving or have within the past 2 month received radio- and/or chemotherapy Currently or having within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment. Are pregnant or breastfeeding Participating in other interventional clinical investigations or have previously participated in this investigation

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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test period<br>The arm consists of a two-week baseline period where subjects apply their own product and a 12 weeks test period where the subjects apply the intervention (SenSura Mio Convex Soft) | Device: SenSura Mio Convex Soft<br>* SenSura Mio Convex Soft is a CE marked ostomy product manufactured by Coloplast<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leakage Under the Baseplate (cm^2) | The leakage area was measured using photos of used baseplates. A computer program was used to measure the leakage area. | 14 weeks (2 weeks baseline + 12 weeks intervention) |