Safety and Performance of New 2-piece Ostomy Product Concept Compared With SenSura Click in Subjects With Ileostomy
July 14, 2014 updated by: Coloplast A/S
Investigating the Safety and Performance of New 2-piece Ostomy Product Concept Compared With SenSura Click in Subjects With Ileostomy
The aim of the current clinical investigation is to evaluate the performance and safety of new 2-piece ostomy product concepts.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The new products have been developed to reduce the degree of leakage and other problems related to ostomy appliances in people with a stoma.
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Humlebæk, Denmark, 3050
- Coloplast A/S
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Have given written informed consent and signed letter of authority form.
- Be at least 18 years of age and have full legal capacity.
- Be able to handle the appliances themselves
- Have an ileostomy with a diameter between 15 and 40 mm.
- Have had their ostomy for at least three months.
- Use minimum 1 baseplate every third day.
- 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)
- Must be able to use custom cut product
- Accept to test three 2-piece products within the study.
- Negative result of a pregnancy test for women of childbearing age.
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.
- More than three days wear time as usual change pattern.
- Currently using ostomy belt
- Currently using extended wear product (Sensura Xpro, Assura TERA, Dansac NovaLife X3, Hollister Flextend, Convatec Durahesive)
- Have a loop ileostomy
- Known hypersensitivity towards any of the test products
- Suffer from peristomal skin problems that preclude participation in the investigation (assessed by the investigation nurse)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Treatment sequence 1
Subjects randomised to Treatment sequence 1 will test three different products:
The subjects test the three test products in a randomized order: ABS; BSA, SAB |
Coloplast A is a newly developed 2-piece ostomy appliance
Coloplast B is a newly developed 2-piece ostomy appliance
The comparator product is the commercial and CE-marked SenSura Click (2-piece) manufactured by Coloplast A/S.
|
|
Experimental: Treatment sequence 2
Subjects randomised to Treatment sequence 2 will test three different products:
The subjects test the three test products in a randomized order: CBS; BSC, SCB |
Coloplast B is a newly developed 2-piece ostomy appliance
The comparator product is the commercial and CE-marked SenSura Click (2-piece) manufactured by Coloplast A/S.
Coloplast C is a newly developed 2-piece ostomy appliance
|
|
Experimental: Treatment sequence 3
Subjects randomised to Treatment sequence 3 will test three different products:
The subjects test the three test products in a randomized order: ACS; CSA, SAC |
Coloplast A is a newly developed 2-piece ostomy appliance
The comparator product is the commercial and CE-marked SenSura Click (2-piece) manufactured by Coloplast A/S.
Coloplast C is a newly developed 2-piece ostomy appliance
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Degree of Leakage
Time Frame: 10 days
|
The degree of leakage is assessed using a 4 point leakage scale developed by Coloplast A/S. The 4-point leakage scale has four choices
Leakage was assessed at every baseplate change |
10 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (Actual)
April 1, 2013
Study Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
February 22, 2013
First Submitted That Met QC Criteria
February 26, 2013
First Posted (Estimate)
February 28, 2013
Study Record Updates
Last Update Posted (Estimate)
August 6, 2014
Last Update Submitted That Met QC Criteria
July 14, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CP234
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.