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An Investigation of Ostomy Devices

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ClinicalTrials.gov Identifier: NCT01514136
Recruitment Status : Completed
First Posted : January 20, 2012
Results First Posted : January 29, 2015
Last Update Posted : March 11, 2015
Information provided by (Responsible Party):
Coloplast A/S

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 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 weeks. Each device will be tested for 7 (± 2) days.

Condition or disease Intervention/treatment
Ileostomy Device: Ostomy appliance: convex 1-piece drainable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: CP216: An Exploratory Investigation of Convex Ostomy Devices
Study Start Date : September 2011
Primary Completion Date : December 2011
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ostomy
U.S. FDA Resources

Arm Intervention/treatment
Experimental: One arm
The arm consists of two periods: in period one, products are tested in the order A, B, C, D, and in period two, products are tested in the order A*, B*, C*, D*.
Device: Ostomy appliance: convex 1-piece drainable
8 variations of an ostomy devices are tested

Primary Outcome Measures :
  1. Degree of Leakage [ Time Frame: One week ]

    The degree of leakage under the baseplate was measured on a 24-point scale where 0 point was the best possible outcome with no leakage under the baseplate and 24-point was the worst possible outcome with leakage under the whole plate.

    The scale was developed by Coloplast A/S

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01514136

Coloplast A/S
Humlebaek, Denmark, 3050
Sponsors and Collaborators
Coloplast A/S
Principal Investigator: Birte P Jakobsen, MD Coloplast A/S

Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT01514136     History of Changes
Other Study ID Numbers: CP216
First Posted: January 20, 2012    Key Record Dates
Results First Posted: January 29, 2015
Last Update Posted: March 11, 2015
Last Verified: February 2015