Clinical Investigation of an Improved Two-piece Stoma Product for People Living With a Stoma

Study Overview
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Brief Summary
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Open-label, randomized, controlled, comparative, cross-over study with 2 test sequences comparing a new 2p coupling system with SenSura Mio Click.

Detailed Description
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Open-label, randomized, controlled, comparative, cross-over study with 2 test sequences comparing a new 2p coupling system with SenSura Mio Click. Each test period is 3 weeks (± 2 days), total study period is 6 weeks (± 4 days). It will be a 1:1 randomization into the two possible treatment sequences. The investigation will require 50 randomized subjects (exp. 20% drop-out), leading to at least 40 completed subjects. The sample size calculation is based on at least 6 bag changes during each test period (≥2 chang-es per week). All visits will be performed as remote virtual calls. At the visits, the investigator (or designee) will give in-structions for the coming period and check that the trial is running as planned. At every bag change the sub-ject will be asked to complete a questionnaire.

Official Title
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A Randomized, Controlled Clinical Investigation of an Improved Two-piece Stoma Product for People Living With a Stoma

Conditions
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Stoma Site Leakage

Intervention / Treatment
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* Device: Iris - new coupling
* Device: Sensura Mio Click


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has given written consent to participate by signing the Informed Consent Signature Form Be at least 18 years of age and have full legal capacity Is able to handle (apply, remove, cut, etc.) the product and do the assessments themselves Has an ileostomy or colostomy with consistent liquid fecal output (for colostomy: 6-7 Bristol stool scale*) *See appendix 1 Currently use SenSura Mio Click 2p Click flat or concave with 50 mm coupling size Have had their ostomy for at least 90 days Be willing to change the bag at least twice per week Is willing and suitable (determined by the Principal Investigator or designee) to use flat or concave 2p open product during the investigation Is willing to use 2p maxi open bags during the investigation Exclusion Criteria: Is currently receiving or have within the past 60 days received radio-and/or chemotherapy - low doses radio- and/or chemotherapy (assessed by Principal Investigator) is allowed for indications other than cancer. Is currently receiving or have within the past 30 days received topical steroid treatment in the peristomal skin area, e.g., lotion or spray Low dose systemic steroid treatment (e.g., inhalation) assessed by the investigator are allowed. Other systemic steroid treatment (e.g., injection or tablet) are not allowed. Is pregnant and/or breast-feeding Have a loop ileostomy Is currently using convex baseplate Has known hypersensitivity towards any of the products used in the 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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New Coupling<br> | Device: Iris - new coupling<br>* SenSura Mio Click maxi bag (open, wide outlet), 50mm Ø with new coupling and lock ring Baseplate flat: SenSura Mio, click base plate with belt ears, 50 mm, 10-45 mm with improved weld-ing bead Baseplate Concave: Item 18510 SenSura Mio Concave, click base plate with ears size Ø50, 10-45 mm<br>|
| Active Comparator: Comparator Device<br> | Device: Sensura Mio Click<br>* SenSura Mio Click 2p bag, item #11472. Open, wide outlet, maxi, neutral grey. 50mm with inspection window and circle filter 430 Baseplate flat: Item #10512 SenSura Mio Click Base Plate with belt ears, 50 mm, 10-45 mm Baseplate concave: Item #18510 SenSura Mio Concave, click base plate with ears size Ø50, 10-45 mm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coupling Leakage | Leakage through coupling registered at each bag change (yes/no). | 3 weeks |