Investigation of Two Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy and Colostomy

August 18, 2016 updated by: Coloplast A/S
The aim of the current investigation is to develop new soft and more flexible 1-piece convex ostomy products.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  1. Have given written informed consent and signed letter of authority.
  2. Are at least 18 years of age and have full legal capacity.
  3. Have had their ostomy (ileo- or colostomy) for at least 3 months.
  4. Have used a 1-piece convex ostomy product during the last month.
  5. Are willing and able to comply with investigation procedures.
  6. Have a ostomy with a diameter of 33 mm or less.

Exclusion Criteria:

  1. Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).
  2. Currently receiving or have within the past 2 month received radio- and/or chemotherapy.
  3. Currently receiving or have within the past month received local (peristomal area) or systemic steroid treatment.
  4. Are pregnant or breastfeeding.
  5. Have a loop ostomy (also called double-barrel or ostomy with two outlets).
  6. Known hypersensitivity toward any of the test products.
  7. Use irrigation during the investigation (flush the stoma with water).
  8. Participating in other interventional clinical investigations or have previously participated in this investigation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FirstColplast Test V, Then Coloplast Test X
The subject tests two experimental coloplast products in a randomised order. Coloplast Test product V and after cross over ColoplastTest product X
Device: Coloplast Test V
Coloplast Test product V is a newly developed 1-piece ostomy appliance
Other Names:
  • Coloplast 1-piece convex Test product V
Device: Coloplast Test X
Coloplast Test X is a newly developed 1-piece ostomy appliance
Other Names:
  • Coloplast 1-piece convex Test product X
Experimental: First Coloplast Test X, Then Coloplast Test V
The subjects test the two experimental Coloplast products in a randomised order: Coloplast Test product X and after cross over Coloplast Test product V
Device: Coloplast Test V
Coloplast Test product V is a newly developed 1-piece ostomy appliance
Other Names:
  • Coloplast 1-piece convex Test product V
Device: Coloplast Test X
Coloplast Test X is a newly developed 1-piece ostomy appliance
Other Names:
  • Coloplast 1-piece convex Test product X

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of Leakage
Time Frame: 14 days

The degree of leakage is measured using a 32-point scale developed by Coloplast A/S, where 0 represents No leakage (the best possible outcome) and 32 points represents full plate leakage (worst possible outcome).

The degree of leakage is measured at each baseplate change
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coloplast A/S

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

August 6, 2013

First Submitted That Met QC Criteria

October 1, 2013

First Posted (Estimate)

October 8, 2013

Study Record Updates

Last Update Posted (Estimate)

September 26, 2016

Last Update Submitted That Met QC Criteria

August 18, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • CP239

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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