An Investigation of Ostomy Devices

CP216: An Exploratory Investigation of Convex Ostomy Devices

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.

Study Overview

• Status: Completed
• Conditions: Ileostomy
• Intervention / Treatment: Device: Ostomy appliance: convex 1-piece drainable

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Humlebaek, Denmark, 3050
    • Coloplast A/S

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of Leakage	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	One week

Collaborators and Investigators

• Sponsor: Coloplast A/S
• Investigators: Principal Investigator: Birte P Jakobsen, MD, Coloplast A/S

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: January 10, 2012
• First Submitted That Met QC Criteria: January 17, 2012
• First Posted (Estimate): January 20, 2012

Study Record Updates

• Last Update Posted (Estimate): March 11, 2015
• Last Update Submitted That Met QC Criteria: February 20, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: CP216