Status:
COMPLETED
Safety and Performance of New 1-piece Ostomy Product
Lead Sponsor:
Coloplast A/S
Conditions:
Stoma Ileostomy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of the the current investigation is to develop new soft and more flexible 1-piece ostomy products.
Detailed Description
The present investigation aims at testing the degree of leakage with the new flexible 1-piece ostomy products as well as other performance and safety parameters.
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 bags themselves.
- Have an ileostomy with a diameter between 15 and 40 mm.
- Have had their ostomy for at least three months.
- Currently use a 1-piece flat ostomy appliance with open bag.
- Use minimum 1 ostomy appliance every second day.
- Be suitable for participation in the investigation and for using standard adhesive, flat base plate.
- Must be able to use a custom cut ostomy appliance.
- Accept to test three 1-piece ostomy appliances in the investigation.
- Negative result of a pregnancy test for women of childbearing age (only DK).
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 months 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.
- Currently using ostomy belt.
- Currently using extended wear product.
- 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 :
May 1 2013
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT01800916
Start Date
February 1 2013
End Date
May 1 2013
Last Update
April 14 2017
Active Locations (1)
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1
Holtedam 3
Humlebæk, Denmark, 3050