Investigating the Safety and Performance of SenSura Test Product in Subjects With Ileostomy
NCT ID: NCT02887144
Last Updated: 2016-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
72 participants
INTERVENTIONAL
2016-01-31
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
DOUBLE
Study Groups
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SenSura test product 1pc
Subjects randomized to treatment sequence 1test:
1. SenSura test product
2. SenSura
SenSura
SenSura is a Commercial and CE-marked ostomy product (1pc) manufactured by Coloplast A/S
SenSura test product
SenSura test product is a CE-marked ostomy product (1pc) manufactured by Coloplast A/S
SenSura 1pc
Subjects randomized to treatment sequence 2 test:
1. SenSura
2. SunSura test product
SenSura
SenSura is a Commercial and CE-marked ostomy product (1pc) manufactured by Coloplast A/S
SenSura test product
SenSura test product is a CE-marked ostomy product (1pc) manufactured by Coloplast A/S
Interventions
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SenSura
SenSura is a Commercial and CE-marked ostomy product (1pc) manufactured by Coloplast A/S
SenSura test product
SenSura test product is a CE-marked ostomy product (1pc) manufactured by Coloplast A/S
Eligibility Criteria
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Inclusion Criteria
2. Be at least 18 years of age and have full legal capacity
3. Be able to handle the products themselves
4. Have an ileostomy (end or loop ostomy) with a diameter between 10 - 40 mm
5. Have had their ileostomy for at least 3 months
6. Have used a 1-piece flat or convex light ostomy appliance with an open bag within the last month
7. Currently using midi or maxi bags
8. Willing to use minimum 1 product every second day (max. 2 days wear time)
9. Be mentally and physically capable of understanding and following the study procedures and completing the Case Report Form
10. Must be able to cut products themselves
Exclusion Criteria
2. Currently receiving or have received within the past month local or systemic steroid treatment in the peristomal area
3. Are pregnant or breastfeeding
4. Participating in other interventional clinical investigations or have previously participated in this investigation
5. Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).
6. Known hypersensitivity of the product components and/or ingredients
18 Years
ALL
No
Sponsors
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Coloplast A/S
INDUSTRY
Responsible Party
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Locations
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Coloplast A/S
Humlebæk, , Denmark
Countries
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Other Identifiers
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Coloplast - CP257
Identifier Type: -
Identifier Source: org_study_id
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