Ileostomy - Stoma Clinical Trial
Official title:
A Clinical Investigation Evaluating and Understanding Parameters Affecting the Performance of Ostomy Products
NCT number | NCT02517541 |
Other study ID # | CP259 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2015 |
Est. completion date | March 2016 |
Verified date | November 2022 |
Source | Coloplast A/S |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of the study is to obtain an understanding of relevant parameters affecting the performance of ostomy products.
Status | Completed |
Enrollment | 74 |
Est. completion date | March 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Have given written informed consent - Be at least 18 years of age and have full legal capacity - Have an ileostomy or colostomy - Have had their ostomy for at least 3 months - Must use 1 piece open or closed ostomy products during the test period - Currently using a 1 piece. flat product - Must be able to use custom cut product - Have intact peristomal skin - 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 Exclusion Criteria: - Currently receiving or have within the past 2 month received radio- and/or chemotherapy - Currently or having within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment. - Are pregnant or breastfeeding - Participating in other interventional clinical investigations or have previously participated in this investigation |
Country | Name | City | State |
---|---|---|---|
Netherlands | QPS Netherlands | Groningen | |
Norway | Helse Nordbyen | Larvik | |
United Kingdom | Synexus Midlands | Birmingham | |
United Kingdom | Pilgrim Hospital | Boston | |
United Kingdom | Cheltenham General Hospital | Cheltenham | |
United Kingdom | Kettering General hospital | Kettering | |
United Kingdom | Lincon Country hospital | Lincoln | |
United States | University of Chicago Medicine | Chicago | Illinois |
United States | Prism research center | Saint Paul | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Coloplast A/S |
United States, Netherlands, Norway, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Leakage Under the Baseplate (cm^2) | The leakage area was measured using photos of used baseplates. A computer program was used to measure the leakage area. | 14 weeks (2 weeks baseline + 12 weeks intervention) |
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