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An Investigation of Ostomy Devices

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT01514136
First received: January 10, 2012
Last updated: January 20, 2012
Last verified: January 2012
History of Changes

January 10, 2012
January 20, 2012
September 2011
December 2011   (final data collection date for primary outcome measure)
area of leakage [ Time Frame: One week ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01514136 on ClinicalTrials.gov Archive Site
Not Provided
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An Investigation of Ostomy Devices
CP216: An Exploratory Investigation of Convex Ostomy Devices

Coloplast A/S has developed 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 secondary objective is to investigate several performance and safety parameters of the various devices.

The aim of the primary and secondary objectives is to acquire more knowledge about the performance of the newly developed device and inspiration for their further development, if needed.

Given that the investigation is exploratory, pass/fail criteria are not relevant. The investigation result will provide knowledge useful for continued decision-making/device development.

The investigation is designed as a non-blinded, controlled, exploratory investigation that includes a total of 30-40 Danish ileostomy users.

Each subject will test a maximum of 4 convex devices in two rounds of each 4 wk. Each device will be tested for 7 (± 2) days.
Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Ileostomy
Device: Ostomy appliance: convex 1-piece drainable
8 variations of an ostomy devices is tested
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
January 2012
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01514136
CP216
No
Coloplast A/S
Coloplast A/S
Not Provided
Principal Investigator: Birte P Jakobsen, MD Coloplast A/S
Coloplast A/S
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP