Assessment of the Performance of a New Ostomy Device in Subjects Having an Ileostomy

Study Overview
=================
Brief Summary
-----------------
The purpose was to investigate the performance of a new ostomy device measured with a measuring device.

Official Title
-----------------
Assessment of the Performance of a New Ostomy Device in Sub-jects Having an Ileostomy

Conditions
-----------------
Ileostomy - Stoma

Intervention / Treatment
-----------------
* Device: Coloplast ostomy device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have given written informed consent and in DK: signed a letter of authority Be at least 18 years of age and have full legal capacity Have had their ileostomy for at least 3 months Can use a product with max cut size 45 mm Self-reported problems with leakage (3 x within 14 days) Be willing and suitable (determined by the investigator representative) to use the test product without using a paste/mouldable ring during the test period Must be able to use custom cut product Minimum change of product every third day Get a negative result of a pregnancy test for women of childbearing age (only DK) Exclusion Criteria: Are currently receiving or have within the past 2 months received radio-and/or chemotherapy (low doses chemotherapy is allowed for other indications than cancer, e.g. below 15 mg methotrexate for rheumatoid arthritis) Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area, e.g. lotion or spray. Systemic steroid treatment (e.g. injection, or tablet) are allowed. Are pregnant or breastfeeding Are participating in other interventional clinical investigations or have previously participated in this investigation Exception: Participation in other Coloplast in-house clinical investigations is accepted under the circumstances that the subject has paused the activities in the investigation and are otherwise complying with the inclusion and exclusion criteria of this (CP278) protocol. Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator) Have known hypersensitivity towards any of the products used in the investigation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The trial starts with a baseline period. After 4 baseplate changes the subjects is randomised into two arms.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Silent arm<br>The participants test the new Coloplast ostomy device use the product as they usually would. | Device: Coloplast ostomy device<br>* the test product is a newly developed Coloplast ostomy device<br>|
| Experimental: Active arm<br>The participants test the tnew Coloplast ostomy device and are guided by the measuring device | Device: Coloplast ostomy device<br>* the test product is a newly developed Coloplast ostomy device<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wear time (hours) | Wear time is recorded at each baseplate change | 14 days |