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OpenTrials
Completed

NCT Number: NCT01957397

Investigation of Three Newly Developed 2-piece Convex Base-plates in Subjects With Ileostomy

To investigate the performance and safety of the three 2-piece convex ostomy appliances

Completed

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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

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

Subjects interested in participating in the clinical investigation must comply with the following criteria:

  • Are at least 18 years of age and have full legal capacity
  • Have had an ileostomy for at least 3 months.
  • Have used a convex ostomy appliance for the last month
  • Have given written informed consent
  • Have an ileostomy with a diameter of 33mm or less
  • Have experienced leakage (seeping) under the baseplate at least two times over the last two weeks

Exclusion criteria

Subjects complying with the following criteria must be excluded from participation in the clinical investigation:

  • Have a loop ostomy (also called double-barrel or ostomy with two outlets)
  • Are pregnant* or breastfeeding.
  • Currently receiving, or have received within the last 2 months, chemotherapy or radiation therapy.
  • Currently receiving or have received, within the last month, systemic or local steroid treatment (adrenocortical hormone) in the peristomal area.
  • Currently suffering from peristomal skin problems (i.e. bleeding or broken skin (weeping skin)).
  • Known hypersensitivity toward any of the test products

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Treatment and study plan

Coloplast Test 1

Device

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

Coloplast Test 2

Device

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

Coloplast Test 3

Device

Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance

Primary outcomes

  1. Degree of Leakage

    Time frame: 14 days

    The degree of leakage was measured with a 32 -point scale developed by Coloplast A/S, where 0 is the best possible outcome (no leakage) and 32 is the worst possible outcome (full leakage under the baseplate)

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Oct 8, 2013
Registry last updated
Sep 30, 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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