Status:
COMPLETED
Performance Study of Newly Developed Ostomy Products
Lead Sponsor:
Coloplast A/S
Conditions:
Stoma Colostomy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of the study is to evaluate leakage of a newly developed ostomy product compared to standard care in subjects with colostomies. Subjects will be asked to use each test product for 2 weeks ...
Eligibility Criteria
Inclusion
- Have given written informed consent.
- Be at least 18 years of age and have full legal capacity.
- Have experienced leakage under the base plate at least once a week over the last two weeks.
- Be able to handle the bags themselves or with help from caregiver (e.g. spouse).
- Have a colostomy with a diameter between 20 and 45 mm.
- Have had their ostomy for at least three months.
- Currently use a 1-piece flat product with closed bag.
- Use minimum 1 product per day.
- Be suitable for participation in the investigation and for using a standard adhesive, flat base plate (evaluated by investigator).
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.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT01513330
Start Date
November 1 2011
End Date
August 1 2012
Last Update
January 9 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Publicare
Cologne, Køln, Germany