Safety and Performance of New 1-piece Ostomy Product

March 17, 2017 updated by: Coloplast A/S

Investigating the Safety and Performance of New 1-piece Ostomy Product Concepts Compared With SenSura 1-piece in Subjects With an Ileostomy

The aim of the the current investigation is to develop new soft and more flexible 1-piece ostomy products.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The present investigation aims at testing the degree of leakage with the new flexible 1-piece ostomy products as well as other performance and safety parameters.

Study Type

Interventional

Enrollment (Actual)

65

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
        • Holtedam 3

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

14 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 form.
  2. Be at least 18 years of age and have full legal capacity.
  3. Be able to handle the bags themselves.
  4. Have an ileostomy with a diameter between 15 and 40 mm.
  5. Have had their ostomy for at least three months.
  6. Currently use a 1-piece flat ostomy appliance with open bag.
  7. Use minimum 1 ostomy appliance every second day.
  8. Be suitable for participation in the investigation and for using standard adhesive, flat base plate.
  9. Must be able to use a custom cut ostomy appliance.
  10. Accept to test three 1-piece ostomy appliances in the investigation.
  11. Negative result of a pregnancy test for women of childbearing age (only DK).

Exclusion Criteria:

  1. Use irrigation during the study (flush the stoma with water).
  2. Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
  3. Currently receiving or have within the past months received local or systemic steroid treatment in the peristomal area.
  4. Are pregnant or breastfeeding.
  5. Participating in other interventional clinical investigations or have previously participated in this investigation.
  6. Currently using ostomy belt.
  7. Currently using extended wear product.
  8. Known hypersensitivity towards any of the test products
  9. Suffer from peristomal skin problems that preclude participation in the investigation (assessed by the investigation nurse) -

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: Treatment sequence 1

The subjects randomised to Treatment sequence 1 are going to test

  1. Coloplast Adhesive baseplate A (A)
  2. Coloplast Adhesive baseplate B (B)
  3. SenSura 1-piece (S)

The subjects test the three test products in a randomised order: ABS; BSA; SAB
Device: Coloplast Adhesive baseplate A
Coloplast Adhesive baseplate A is a newly developed 1-piece ostomy appliance.
Device: Coloplast Adhesive baseplate B
Coloplast Adhesive baseplate B is a newly developed 1-piece ostomy appliance
Device: SenSura 1-Piece
SenSura 1-piece is the commercial CE-marked Coloplast 1-piece SenSura .
Experimental: Treatment sequence 2

The subjects randomised to Treatment sequence 2 are going to test

  1. Coloplast Adhesive baseplate B (B)
  2. Coloplast Adhesive baseplate C (C)
  3. SenSura 1-piece (S)

The subjects test the three test products in a randomised order: CBS; BSC; SCB
Device: Coloplast Adhesive baseplate B
Coloplast Adhesive baseplate B is a newly developed 1-piece ostomy appliance
Device: SenSura 1-Piece
SenSura 1-piece is the commercial CE-marked Coloplast 1-piece SenSura .
Device: Coloplast Adhesive baseplate C
Coloplast Adhesive baseplate C is a newly developed 1-piece ostomy appliance
Experimental: Treatment sequence 3

The subjects randomised to Treatment sequence 3 are going to test

  1. Coloplast Adhesive baseplate A (A)
  2. Coloplast Adhesive baseplate B (C)
  3. SenSura 1-piece (S)

The subjects test the three test products in a randomised order: ACS; CSA; SAC
Device: Coloplast Adhesive baseplate A
Coloplast Adhesive baseplate A is a newly developed 1-piece ostomy appliance.
Device: SenSura 1-Piece
SenSura 1-piece is the commercial CE-marked Coloplast 1-piece SenSura .
Device: Coloplast Adhesive baseplate C
Coloplast Adhesive baseplate C is a newly developed 1-piece ostomy appliance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of Leakage
Time Frame: one week

The degree of leakage is measured using a 4-point leakage scale developed by Coloplast A/S at every baseplate change.

The subjects had to tick off one of the following choices:

  1. No leakage
  2. Starting to leak
  3. Leakage
  4. Sudden Leakage
one week

Collaborators and Investigators

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

Sponsor

Coloplast A/S

Investigators

  • Principal Investigator: Birte Jakobsen, Dr., 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

February 1, 2013

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

February 22, 2013

First Submitted That Met QC Criteria

February 27, 2013

First Posted (Estimate)

February 28, 2013

Study Record Updates

Last Update Posted (Actual)

April 14, 2017

Last Update Submitted That Met QC Criteria

March 17, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CP236

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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