N/A
N=38
Investigation of a New 1-piece Convex Ostomy Product
Stoma Ileostomy · Stoma Colostomy
Bottom Line
View on ClinicalTrials.gov: NCT02043782 ↗Enrolled (actual)
38
Serious AEs
1.8%
Results posted
Dec 2015
Primary outcome: Primary: Degree of Leakage — 2.6; 4.8; 2.5 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Coloplast Test (Device); Own product (Device); Competitor soft convex (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Coloplast A/S
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Degree of Leakage |
2.6; 4.8; 2.5 | — |
Summary
The aim of the investigation was to investigate the performance and safety of a new ostomy product
Eligibility Criteria
Inclusion Criteria
- Are at least 18 years of age and have full legal capacity.
- Have had an ileostomy/colostomy for more than 3 months
- Have used a 1-piece flat ostomy product for the last 1 month
- Has given written Informed Consent and signed the letter of authority
- Have an ileostomy or colostomy with a diameter of 33 mm or less
- Has experienced leakage (seeping) under the baseplate at least three times during the last two weeks
- Are evaluated to be suitable for a soft convex product
- If having a colostomy: changes their product on average 2 times pr. 24h or more
- Currently uses a bag of size medi/midi or maxi
Exclusion Criteria
- Have a loop ostomy (also called double-barrel or ostomy with two outlets).
- Are pregnant or breastfeeding
- Currently receiving or have within the past 2 month received radio- and/or chemotherapy
- Currently receiving or have within the past month received systemic or local steroid treatment in the peristomal area
- Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).
- Known hypersensitivity toward any of the test products
- Participating in other interventional clinical investigations or have previously participated in this investigation
- Use irrigation during the investigation (flush the intestine with water)
- Have a fistula in the peristomal area or less than 2 cm from the edge of the baseplate
- If subject has a colostomy: empties the bag
Data sourced from ClinicalTrials.gov (NCT02043782). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.