Performance Study of Newly Developed Ostomy Products

Study Overview
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Brief Summary
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The purpose of the study is to evaluate leakage of a newly developed ostomy product compared to standard care in subjects with colostomies. Subjects will be asked to use each test product for 2 weeks - in total, the study period is 4 weeks and the hypothesis is to show that the newly developed ostomy product is significantly better to reduce leakage compared to standard care.

Official Title
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An Open-labelled, Randomised, Controlled, Crossover Investigation Evaluating Performance of a Newly Developed Ostomy Care Product Compared to Standard Care.

Conditions
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Stoma Colostomy

Intervention / Treatment
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* Device: SenSura Mio
* Device: Standard Care


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 experienced leakage under the base plate at least once a week over the last two weeks. Be able to handle the bags themselves or with help from caregiver (e.g. spouse). Have a colostomy with a diameter between 20 and 45 mm. Have had their ostomy for at least three months. Currently use a 1-piece flat product with closed bag. Use minimum 1 product per day. Be suitable for participation in the investigation and for using a standard adhesive, flat base plate (evaluated by investigator). 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.

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: First Standard Care, then SenSura Mio<br>Subjects first test Standard Care (Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima) and after cross-over SenSura Mio | Device: SenSura Mio<br>* Ostomy product - 1 piece closed bag<br>Device: Standard Care<br>* Ostomy product 1 piece closed bags. Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima.<br>|
| Experimental: First SenSura Mio, then Standard Care<br>Subjects first test SenSura Mio and after cross-over Standard Care(Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima) | Device: SenSura Mio<br>* Ostomy product - 1 piece closed bag<br>Device: Standard Care<br>* Ostomy product 1 piece closed bags. Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of Leakage. Each Baseplate Can Have a Score From 0-24 Points Were 0 is the Best Possible Outcome (No Leakage) and 24 Points is the Worst Possible Outcome (Full Plate Leakage) | Degree of leakage will be measured by a 25-point leakage scale (no leakage or up till 24 points of leakage), developed by Coloplast A/S. The subjects receive Petri dishes with pre-printed leakage scale on. The subject will place the Petri dish above the used baseplate and indicate where on the baseplate output appears. This is done by ticking of each area on the scale indicating the area of leakage. | 14 days |