Investigation of Newly Developed Ostomy Products in Subjects With Ileostomy
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ClinicalTrials.gov Identifier: NCT01994902 |
Recruitment Status :
Completed
First Posted : November 26, 2013
Results First Posted : January 12, 2016
Last Update Posted : January 12, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Stoma Ileostomy | Device: Coloplast test product Device: SenSura Convex Light | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 129 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Investigation of Newly Developed 1-and 2-piece Convex Ostomy Products in Subjects With Ileostomy. |
Study Start Date : | November 2013 |
Actual Primary Completion Date : | June 2014 |
Actual Study Completion Date : | June 2014 |
Arm | Intervention/treatment |
---|---|
Experimental: First Coloplast test product
The subjects test: test period 1: Coloplast test product test period 2: SenSura Convex Light |
Device: Coloplast test product
The Coloplast test product is a newly developed ostomy appliance Device: SenSura Convex Light The comparator product is SenSura Convex Light, which is CE-marked and commercially available.
Other Name: SenSura |
Experimental: First SenSura Convex Light
The subjects test: test period 1: SenSura Convex Light test period 2: Coloplast test product |
Device: Coloplast test product
The Coloplast test product is a newly developed ostomy appliance Device: SenSura Convex Light The comparator product is SenSura Convex Light, which is CE-marked and commercially available.
Other Name: SenSura |
- Degree of Leakage [ Time Frame: 28 +/- 3 days ]The degree of leakage is measured using a 33-point scale measuring leakage under the baseplate, where 0 points represents the best possible outcome (no leakage) and 33 points the worst possible outcome (leakage on the whole baseplate).

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Are at least 18 years of age and have full legal capacity.
- Has had an ileostomy for at least 3 months.
- Has used a convex ostomy product for the last month.
- Has given signed informed consent.
- Has experienced seeping under the baseplate at least three times during the last two weeks.
- Currently using a SenSura Convex product with midi, maxi or magnum bags.
- Currently using a 1-piece product or a 2-piece product with a mechanical coupling ("click coupling").
- Has an ileostomy with a diameter of max 33 mm (1-piece product) or less. Or Has an ileostomy with a diameter of 30 mm (2-piece product) or less.
Exclusion Criteria:
- Has a loop-ostomy (double-barrel ostomy or ostomy with two outlets).
- Are pregnant or breastfeeding.
- Currently receiving, or has within the past 2 months received radio- and/or chemotherapy.
- Currently receiving, or has within the past month received steroid treatment (adrenocortical hormone) systemically or locally in the peristomal area.
- Currently suffering from peristomal skin problems i.e. bleeding or broken (weeping) skin.
- Are currently participating in another clinical intervention study or have previously participated in this one.
- Has a fistula in the peristomal area or less than 2 cm from the edge of the baseplate.
- Has known hypersensitivity toward the test product.

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): NCT01994902

Study Director: | Daniel Carter | Coloplast A/S |
Responsible Party: | Coloplast A/S |
ClinicalTrials.gov Identifier: | NCT01994902 |
Other Study ID Numbers: |
CP232 |
First Posted: | November 26, 2013 Key Record Dates |
Results First Posted: | January 12, 2016 |
Last Update Posted: | January 12, 2016 |
Last Verified: | December 2015 |