Status:
COMPLETED
Safety and Performance of New 2-piece Ostomy Product Concept Compared With SenSura Click in Subjects With Ileostomy
Lead Sponsor:
Coloplast A/S
Conditions:
Subjects With an Ileostomy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of the current clinical investigation is to evaluate the performance and safety of new 2-piece ostomy product concepts.
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.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01800890
Start Date
February 1 2013
End Date
April 1 2013
Last Update
August 6 2014
Active Locations (1)
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1
Coloplast A/S
Humlebæk, Denmark, 3050