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Completed

NCT Number: NCT01957553

Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared With SenSura Click 2-piece

The aim of the current investigation is to investigate the performance of a new 2-piece ostomy product

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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

Imelda Hospital Bonheiden, Bonheiden, Belgium

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About this study

The present investigation aims at testing the performance and safety of a new 2-piece ostomy product.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 1.Have given written informed consent and letter of authority (DK only)
  • 2.Be at least 18 years of age and have full legal capacity.
  • 3.Be able to handle the products her/himself
  • 4.Have an ileostomy with a diameter between 10 and 40 mm.
  • 5.Have had their ostomy for at least three months.
  • 6.Be willing to use minimum 2 base plates every week
  • 7.Currently use 2-piece flat mechanical coupling product with open bag 8
  • 11.Negative result of a pregnancy test for women of childbearing age (only DK)

Exclusion criteria

  • 1.Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
  • 2.Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
  • 3.Is pregnant or breastfeeding.
  • 4.Is participating in other interventional clinical investigations or have previously participated in this investigation
  • 5.Has participated in the previous explorative study CP234
  • 6.
  • 7.Known hypersensitivity towards any of the test products
  • 8.Currently suffering from peristomal skin problems (i.e.bleeding or red and broken skin)

Treatment and study plan

Coloplast test product

Device

Coloplast test product is a newly developed 2-piece ostomy appliance

SenSura

Device

SenSura is the commercial available CE-marked SenSura Click 2-piece ostomy appliance from Coloplast A/S

Other names: SenSura Click, SenSura Standard 2-piece

Primary outcomes

  1. Preference

    Time frame: 21+1 days

    The subjects were asked which product they preferred (the Test product or SenSura) at the end of the investigation. The preference result shows the percentage of subjects preferring either the Test product or SenSura.

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study title

Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared With SenSura Click in 130 Subjects With an Ileostomy.

Important dates

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

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