Completed
New 2-piece Ostomy Product for Reduced Leakage in Ileostomy Patients
Study Aim
This study aims to evaluate the effectiveness of a new 2-piece ostomy product in reducing leakage in individuals with ileostomy, using a 4-point leakage scale for assessment.
What is being tested
New Coloplast A Ostomy Device
+ New Coloplast B Ostomy Appliance
+ Study on SenSura Click Device
Device
Who is being recruted
Over 18 Years
+21 Eligibility Criteria
How is the trial designed
Supportive Care Study
Interventional
Study Start: February 2013
Summary
Principal SponsorColoplast A/S
Last updated: August 6, 2014
Sourced from a government-validated database.Claim as a partner
Study start date: February 1, 2013
Actual date on which the first participant was enrolled.The new products have been developed to reduce the degree of leakage and other problems related to ostomy appliances in people with a stoma.
Principal SponsorColoplast A/S
Last updated: August 6, 2014
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
31 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
10 inclusion criteria required to participate
Accept to test three 2-piece products within the study
Be able to handle the appliances themselves
Be at least 18 years of age and have full legal capacity
Currently use 2-piece flat mechanical coupling product with open bag and a coupling size in the inter val of 43-55mm (both extremes included)
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11 exclusion criteria prevent from participating
Are pregnant or breastfeeding
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
Currently using extended wear product (Sensura Xpro, Assura TERA, Dansac NovaLife X3, Hollister Flextend, Convatec Durahesive)
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Subjects randomised to Treatment sequence 1 will test three different products:
Coloplast A
Coloplast B
SenSura Click
The subjects test the three test products in a randomized order: ABS; BSA, SAB
Group II
ExperimentalSubjects randomised to Treatment sequence 2 will test three different products:
Coloplast C (C)
Coloplast B (B)
SenSura Click (S)
The subjects test the three test products in a randomized order: CBS; BSC, SCB
Group III
ExperimentalSubjects randomised to Treatment sequence 3 will test three different products:
Coloplast A (A)
Coloplast C (C)
SenSura Click (S)
The subjects test the three test products in a randomized order: ACS; CSA, SAC
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center