CompletedInterventionalNot ApplicableUpdated Mar 10, 2014
An Explorative Randomized Controlled Investigation Evaluating Newly Developed Ostomy Products | NCT02351817 | Trialant
CompletedInterventionalNot ApplicableUpdated Jan 6, 2016
An Explorative Randomized Controlled Investigation Evaluating Newly Developed Ostomy Products
ClinicalTrials.gov ID
NCT02351817
Lead Sponsor
Coloplast A/SINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
10Actual
Last Update Posted
Jan 6, 2016Estimated
Start Date
Feb 2015
Primary Completion Date
Mar 2015Actual
Completion Date
Mar 2015Actual
Brief Summary
The primary objective of the investigation is to explore the acceptance of a newly developed adhesive.
Ileostomy
Test A
Test B
Baseline
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have given written informed consent and letter of authority
Be at least 18 years of age and have full legal capacity
Be able to handle the products her/himself
Have an ileostomy with a diameter between 10 and 30 mm
Willing to follow the product change schedule (one change per day)
Have had their ostomy for at least three months
Willing to use 1 piece open ostomy products during the test period
Must be able to use a custom cut product
Have intact skin
Negative result of a pregnancy test for women of childbearing age
Exclusion Criteria:
Currently receiving or have within the past 2 months received radio- and/or chemotherapy
Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/ injection) treatment
Is pregnant or breastfeeding.
Is participating in other interventional clinical investigations or have previously participated in this investigation
Have a loop ileostomy
Known hypersensitivity towards any of the test products