At a glance
ClinicalIndex Comparison RecordN/ACompleted· 65 enrolled
Drug / intervention
Coloplast Adhesive baseplate A +3 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Investigating the Safety and Performance of New 1-piece Ostomy Product Concepts Compared With SenSura 1-piece in Subjects With an Ileostomy
In Brief
A clinical study evaluating Coloplast Adhesive baseplate A, Coloplast Adhesive baseplate B, and 2 other interventions for Stoma Ileostomy. Completed, enrolled 65 participants across 1 site.
Detailed Summary
The aim of the the current investigation is to develop new soft and more flexible 1-piece ostomy products.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStoma Ileostomy
CountriesDenmark
Collaborators--
Timeline
N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2013
First PostedFeb 2013
Primary CompletionMay 2013
TodayJul 2026
First PostedFeb 28, 2013
Enrollment StartFeb 1, 2013
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 13.3 years ago
Interventions
Coloplast Adhesive baseplate Adevice
Coloplast Adhesive baseplate A is a newly developed 1-piece ostomy appliance.
Coloplast Adhesive baseplate Bdevice
Coloplast Adhesive baseplate B is a newly developed 1-piece ostomy appliance
Coloplast Adhesive baseplate Cdevice
Coloplast Adhesive baseplate C is a newly developed 1-piece ostomy appliance
SenSura 1-Piecedevice
SenSura 1-piece is the commercial CE-marked Coloplast 1-piece SenSura .