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Completed

NCT Number: NCT01957475

Investigation of Two Newly Developed 2-piece Convex Baseplates in Subjects With Ileostomy

The aim of the current investigation is to develop new soft and more flexible 2-piece convex ostomy appliances

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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

Coloplast A/S

Humlebæk, 3050, Denmark

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.
  • Are at least 18 years of age and have full legal capacity.
  • Have had their ileostomy for at least 3 months.
  • Have used a 2-piece convex ostomy product during the last month.
  • Are willing and able to comply with investigation procedures.
  • Have an ileostomy with a diameter of 30 mm or less.
  • Have experienced leakage (seeping) under the baseplate at least 2 times during the last two weeks.

Exclusion criteria

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

Treatment and study plan

Coloplast Test product Y

Device

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

Other names: Coloplast 2-piece Convex appliance Test product Y

Coloplast Test product Z

Device

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

Other names: Coloplast 2-piece convex appliance test product Z

Primary outcomes

  1. 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 (best possible outcome) and 32 points represents full-plate leakage (worst possible outcome).

    The degree of leakage was measured at each baseplate change.

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Oct 8, 2013
Registry last updated
Sep 20, 2016

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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