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OpenTrials
Completed

NCT Number: NCT01800890

Safety and Performance of New 2-piece Ostomy Product Concept Compared With SenSura Click in Subjects With Ileostomy

The aim of the current clinical investigation is to evaluate the performance and safety of new 2-piece ostomy product concepts.

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Key information

Conditions

Subjects With an 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

About this study

The new products have been developed to reduce the degree of leakage and other problems related to ostomy appliances in people with a stoma.

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 appliances themselves
  • Have an ileostomy with a diameter between 15 and 40 mm.
  • Have had their ostomy for at least three months.
  • Use minimum 1 baseplate every third day.
  • Currently use 2-piece flat mechanical coupling product with open bag and a coupling size in the inter val of 43-55mm (both extremes included)
  • Must be able to use custom cut product
  • Accept to test three 2-piece products within the study.
  • Negative result of a pregnancy test for women of childbearing age.

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 month 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.
  • More than three days wear time as usual change pattern.
  • Currently using ostomy belt
  • Currently using extended wear product (Sensura Xpro, Assura TERA, Dansac NovaLife X3, Hollister Flextend, Convatec Durahesive)
  • Have a loop ileostomy
  • 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 A

Device

Coloplast A is a newly developed 2-piece ostomy appliance

Coloplast B

Device

Coloplast B is a newly developed 2-piece ostomy appliance

Coloplast C

Device

Coloplast C is a newly developed 2-piece ostomy appliance

SenSura Click

Device

The comparator product is the commercial and CE-marked SenSura Click (2-piece) manufactured by Coloplast A/S.

Primary outcomes

  1. Degree of Leakage

    Time frame: 10 days

    The degree of leakage is assessed using a 4 point leakage scale developed by Coloplast A/S.

    The 4-point leakage scale has four choices

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

    Leakage was assessed at every baseplate change

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study title

Investigating the Safety and Performance of New 2-piece Ostomy Product Concept Compared With SenSura Click in Subjects With Ileostomy

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 28, 2013
Registry last updated
Aug 6, 2014

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.