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Completed

NCT Number: NCT01800916

Safety and Performance of New 1-piece Ostomy Product

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

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Key information

Conditions

Stoma Ileostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Holtedam 3

Humlebæk, 3050, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Coloplast Adhesive baseplate A

Device

Coloplast Adhesive baseplate A is a newly developed 1-piece ostomy appliance.

Coloplast Adhesive baseplate B

Device

Coloplast Adhesive baseplate B is a newly developed 1-piece ostomy appliance

Coloplast Adhesive baseplate C

Device

Coloplast Adhesive baseplate C is a newly developed 1-piece ostomy appliance

SenSura 1-Piece

Device

SenSura 1-piece is the commercial CE-marked Coloplast 1-piece SenSura .

Primary outcomes

  1. 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:

    • No leakage
    • Starting to leak
    • Leakage
    • Sudden Leakage

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 28, 2013
Registry last updated
Apr 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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