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Completed

NCT Number: NCT01957488

Investigating the Safety and Performance of Two New 1-piece Ostomy Products Compared With SenSura 1-piece

The aim of the current investigation is to investigate the performance of two new 1-piece ostomy products

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Key information

Conditions

Ileostomy - Stoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Holtedam 3, Humlebæk, Denmark

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About this study

The present investigation aims at testing the performance and safety of the two new 1-piece ostomy products

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 (mandatory in DK)
  • Be at least 18 years of age and have full legal capacity.
  • Be able to handle the products themselves
  • Have an ileostomy with a diameter between 10 and 40 mm.
  • Have had their ostomy for at least three months.
  • Have within the last month used a 1-piece flat product with open bag
  • Currently using midi or maxi bags
  • Willing to use minimum 1 product every second day, i.e. maximum 2 days wear time.
  • Be suitable for participation in the investigation
  • Must be able to use custom cut product
  • Negative result of a pregnancy test for women of childbearing age (only DK)

Exclusion criteria

  • Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
  • Currently receiving or have within the past month received systemic steroid or local treatment in the peristomal area
  • Are pregnant or breastfeeding
  • Participating in other interventional clinical investigations or have previously participated in this investigation
  • Has participated in the previous explorative Coloplast studies CP236 and CP237
  • Are currently or during the study using ostomy belt
  • Has a stoma below skin surface
  • Currently suffering from peristomal skin problems (i.e.bleeding and/or broken skin)
  • Has known hypersensitivity towards any of the test products

Treatment and study plan

Coloplast Test product 1

Device

Coloplast Test product 1 is a newly developed 1-piece ostomy appliance

Coloplast Test product 2

Device

Coloplast Test product 2 is a newly developed 1-piece ostomy appliance

Coloplast SenSura

Device

SenSura 1-piece is the commercial available CE-marked SenSura 1-piece from Coloplast A/S.

Other names: SenSura 1-piece

Primary outcomes

  1. Leakage

    Time frame: 14 +- 1 days

    The fraction of baseplates with No leakage/seeping under the baseplate was measured. Leakage/seeping under the baseplate was assessed after each baseplate change.

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study title

Investigating the Safety and Performance of Two New 1-piece Ostomy Products in 180 Subjects With Ileostomy

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Oct 8, 2013
Registry last updated
Sep 10, 2020

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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