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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01957553
Recruitment Status : Completed
First Posted : October 8, 2013
Results First Posted : September 8, 2014
Last Update Posted : September 8, 2014
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S

Study Description
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Brief Summary:
The aim of the current investigation is to investigate the performance of a new 2-piece ostomy product

Condition or disease Intervention/treatment Phase
Ileostomy - Stoma Device: Coloplast test product Device: SenSura Not Applicable

Detailed Description:
The present investigation aims at testing the performance and safety of a new 2-piece ostomy product.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared With SenSura Click in 130 Subjects With an Ileostomy.
Study Start Date : September 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ostomy

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment sequence 1, First Coloplast Test product
Subjects first allocated to Coloplast Test product will after cross-over test SenSura
 Device: Coloplast test product
Coloplast test product is a newly developed 2-piece ostomy appliance

Device: SenSura
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
Experimental: Treatment seqence 2; First SenSura
Subjects first allocated to SenSura will after cross-over test Coloplast Test product
 Device: Coloplast test product
Coloplast test product is a newly developed 2-piece ostomy appliance

Device: SenSura
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


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01957553


Locations
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Sponsors and Collaborators
Coloplast A/S
Investigators
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Principal Investigator: Birte P Jakobsen, MD Coloplast A/S
More Information
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Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT01957553    
Other Study ID Numbers: CP243
First Posted: October 8, 2013    Key Record Dates
Results First Posted: September 8, 2014
Last Update Posted: September 8, 2014
Last Verified: September 2014