Evaluation of a New Supporting Ostomy Product

  • STATUS
    Recruiting
  • participants needed
    30
  • sponsor
    Coloplast A/S
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Updated on 19 February 2024
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Summary

The aim of the study is to evaluate if the new supporting product influences wear time. It is the expectation that median wear time is slightly reduced in the period when subjects are using the supporting product with their ostomy appliance. Long-term benefits of the test product may be less skin redness, less worry of leakage and/or improvement in quality of life and social activities.

Details
Condition Stoma Ileostomy
Age 18-100 years
Treatment CP308
Clinical Study IdentifierNCT04374890
SponsorColoplast A/S
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Have given written informed consent
Be at least 18 years of age and have full legal capacity
Have had a stoma for more than three months
Have intact skin on the area used in the evaluation meaning no broken skin and only minor discoloration of the skin (assessed by investigator)
Be able to use one of the three test products (i.e. 50, 60 and 70 mm)
Have an ileostomy- or colostomy with liq-uid output (Bristol scale type 6-7)
Currently using a SenSura Mio product (1pc/2pc Flat/Convex/Concave)
Be willing and suitable (determined by the study nurse) to use the test product with-out using a paste/mouldable ring during the test periods
Have self-reported problems with leakage (three times within 14 days) Leakage: Leakage is defined as output from the stoma on the backside of the baseplate (underneath the baseplate)

Exclusion Criteria

Currently receiving or have within the past 2 month received radio- and/or chemotherapy
Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment
Are pregnant or breastfeeding
Participating in other interventional clinical investigations or have previously participat-ed in this investigation. Exception: Participation in other Coloplast sponsored clinical investigations is accepted under the circumstances that the subject has paused the activities in the investigation and are otherwise complying with the inclusion and exclusion criteria of this (CP308) protocol
Known sensitivity towards test product
Known sensitivity towards acrylate
Users with a pacemaker
Clear my responses
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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