N/A
N=26
Investigation of Three Newly Developed 2-piece Convex Base-plates in Subjects With Ileostomy
Ileostomy - Stoma
Bottom Line
View on ClinicalTrials.gov: NCT01957397 ↗Enrolled (actual)
26
Serious AEs
2.1%
Results posted
Apr 2014
Primary outcome: Primary: Degree of Leakage — 4.5; 5.2; 6.4; 6.8 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Coloplast Test 1 (Device); Coloplast Test 2 (Device); Coloplast Test 3 (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Coloplast A/S
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Degree of Leakage |
4.5; 5.2; 6.4; 6.8 | — |
Summary
To investigate the performance and safety of the three 2-piece convex ostomy appliances
Eligibility Criteria
Inclusion Criteria
Subjects interested in participating in the clinical investigation must comply with the following criteria:
- Are at least 18 years of age and have full legal capacity
- Have had an ileostomy for at least 3 months.
- Have used a convex ostomy appliance for the last month
- Have given written informed consent
- Have an ileostomy with a diameter of 33mm or less
- Have experienced leakage (seeping) under the baseplate at least two times over the last two weeks
Exclusion Criteria
Subjects complying with the following criteria must be excluded from participation in the clinical investigation:
- Have a loop ostomy (also called double-barrel or ostomy with two outlets)
- Are pregnant* or breastfeeding.
- Currently receiving, or have received within the last 2 months, chemotherapy or radiation therapy.
- Currently receiving or have received, within the last month, systemic or local steroid treatment (adrenocortical hormone) in the peristomal area.
- Currently suffering from peristomal skin problems (i.e. bleeding or broken skin (weeping skin)).
- Known hypersensitivity toward any of the test products
-
Data sourced from ClinicalTrials.gov (NCT01957397). 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.