Status:
COMPLETED
An Investigation of Ostomy Devices
Lead Sponsor:
Coloplast A/S
Conditions:
Ileostomy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Coloplast A/S has developed a new ostomy device in 8 versions. The primary objective of this investigation is to assess and compare the degree of leakage when using the 8 different devices. The seco...
Eligibility Criteria
Inclusion
- Be at least 18 years old
- Have signed the declaration of informed consent
- Have an ileostomy in a concave area
- Have had an ileostomy for at least three months
- Have used convex plates (for convex users) or flat plates (for flat plate users) for the last month
- Be users of 1-piece or 2-piece open ostomy devices
- Have an ileostomy with a diameter of less than 33 mm
Exclusion
- Are pregnant or breast-feeding
- Have a double-loop ileostomy
- Have known hypersensitivity or allergy to the devices' component ingredients
- Are receiving/have received radiation treatment and/or chemotherapy within the last 3 months.
- Are receiving/have received local peristomal or systemic steroid treatment within the last month
- Suffer from peristomal skin problems that preclude participation in the investigation (assessed by the investigation nurse)
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01514136
Start Date
September 1 2011
End Date
January 1 2012
Last Update
March 11 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Coloplast A/S
Humlebæk, Denmark, Denmark, 3050