Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared With SenSura Click in 130 Subjects With an Ileostomy.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Coloplast A/S
- Enrollment
- 130
- Locations
- 34
- Primary Endpoint
- Preference
Study Overview
Brief Summary
The aim of the current investigation is to investigate the performance of a new 2-piece ostomy product
Detailed Description
The present investigation aims at testing the performance and safety of a new 2-piece ostomy product.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •7.Known hypersensitivity towards any of the test products
- •8.Currently suffering from peristomal skin problems (i.e.bleeding or red and broken skin)
Arms & Interventions
Treatment sequence 1, First Coloplast Test product
Subjects first allocated to Coloplast Test product will after cross-over test SenSura
Intervention: Coloplast test product (Device)
Treatment sequence 1, First Coloplast Test product
Subjects first allocated to Coloplast Test product will after cross-over test SenSura
Intervention: SenSura (Device)
Treatment seqence 2; First SenSura
Subjects first allocated to SenSura will after cross-over test Coloplast Test product
Intervention: Coloplast test product (Device)
Treatment seqence 2; First SenSura
Subjects first allocated to SenSura will after cross-over test Coloplast Test product
Intervention: SenSura (Device)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported