Investigation of a New 1-piece Convex Ostomy Product

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT02043782
First received: January 16, 2014
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

The aim of the investigation was to investigate the performance and safety of a new ostomy product


Condition Intervention
Stoma Ileostomy
Stoma Colostomy
Device: Coloplast Test
Device: Own product
Device: Competitor soft convex

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Investigation of a New 1-piece Convex Ostomy Product in Subjects With Ileostomy and Colostomy

Resource links provided by NLM:


Further study details as provided by Coloplast A/S:

Primary Outcome Measures:
  • Degree of leakage [ Time Frame: 14 +/- 3 days ] [ Designated as safety issue: No ]
    The degree of leakage is investigated on a 33-point scale


Enrollment: 38
Study Start Date: January 2014
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: First Coloplast Test

The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of the treatments to the periods.

First subjects are allocated to Coloplast Test; Secondly to either

  1. Own product (baseline)
  2. Competitor soft convex
Device: Coloplast Test
Newly developed 1 -piece convex ostomy product
Device: Own product
The subjects Own product is used as baseline performance in this investigation. The products are commercial and available on the market, and are products manufactured by manufactures who produce convex ostomy products ie Coloplast, Convatec, Dansac, B.Braun, Hollister and more.
Device: Competitor soft convex
A commercially available soft convex product
Experimental: First Competitor soft convex

The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of the treatments to the periods.

First subjects are allocated to Competitor soft convex; Secondly to either

  1. Own product (baseline)
  2. Coloplast Test
Device: Coloplast Test
Newly developed 1 -piece convex ostomy product
Device: Own product
The subjects Own product is used as baseline performance in this investigation. The products are commercial and available on the market, and are products manufactured by manufactures who produce convex ostomy products ie Coloplast, Convatec, Dansac, B.Braun, Hollister and more.
Device: Competitor soft convex
A commercially available soft convex product
Experimental: First Own product

The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of the treatments to the periods.

First subjects are allocated to Own product; Secondly to either

  1. Coloplast Test
  2. Competitor soft convex
Device: Coloplast Test
Newly developed 1 -piece convex ostomy product
Device: Own product
The subjects Own product is used as baseline performance in this investigation. The products are commercial and available on the market, and are products manufactured by manufactures who produce convex ostomy products ie Coloplast, Convatec, Dansac, B.Braun, Hollister and more.
Device: Competitor soft convex
A commercially available soft convex product

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Are at least 18 years of age and have full legal capacity.
  • Have had an ileostomy/colostomy for more than 3 months
  • Have used a 1-piece flat ostomy product for the last 1 month
  • Has given written Informed Consent and signed the letter of authority
  • Have an ileostomy or colostomy with a diameter of 33 mm or less
  • Has experienced leakage (seeping) under the baseplate at least three times during the last two weeks
  • Are evaluated to be suitable for a soft convex product
  • If having a colostomy: changes their product on average 2 times pr. 24h or more
  • Currently uses a bag of size medi/midi or maxi

Exclusion Criteria:

  • Have a loop ostomy (also called double-barrel or ostomy with two outlets).
  • Are pregnant or breastfeeding
  • Currently receiving or have within the past 2 month received radio- and/or chemotherapy
  • Currently receiving or have within the past month received systemic or local steroid treatment in the peristomal area
  • Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).
  • Known hypersensitivity toward any of the test products
  • Participating in other interventional clinical investigations or have previously participated in this investigation
  • Use irrigation during the investigation (flush the intestine with water)
  • Have a fistula in the peristomal area or less than 2 cm from the edge of the baseplate
  • If subject has a colostomy: empties the bag
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02043782

Locations
Denmark
TFS
Søborg, Denmark
Sponsors and Collaborators
Coloplast A/S
Investigators
Principal Investigator: Birte P Jakobsen, MD Coloplast A/S
  More Information

No publications provided

Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT02043782     History of Changes
Other Study ID Numbers: CP241
Study First Received: January 16, 2014
Last Updated: August 12, 2014
Health Authority: Denmark: Danish Health and Medicines Authority

ClinicalTrials.gov processed this record on October 19, 2014