At a glance
ClinicalIndex Comparison RecordN/ACompleted· 31 enrolled
Drug / intervention
Coloplast 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 2-piece Ostomy Product Concept Compared With SenSura Click in Subjects With Ileostomy
In Brief
A clinical study evaluating Coloplast A, Coloplast B, and 2 other interventions for Subjects With an Ileostomy. Completed, enrolled 31 participants across 1 site.
Detailed Summary
The aim of the current clinical investigation is to evaluate the performance and safety of new 2-piece ostomy product concepts.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSubjects With an Ileostomy
CountriesDenmark
Collaborators--
Timeline
N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2013
First PostedFeb 2013
Primary CompletionApr 2013
TodayJul 2026
First PostedFeb 28, 2013
Enrollment StartFeb 1, 2013
Primary CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 13.3 years ago
Interventions
Coloplast Adevice
Coloplast A is a newly developed 2-piece ostomy appliance
Coloplast Bdevice
Coloplast B is a newly developed 2-piece ostomy appliance
Coloplast Cdevice
Coloplast C is a newly developed 2-piece ostomy appliance
SenSura Clickdevice
The comparator product is the commercial and CE-marked SenSura Click (2-piece) manufactured by Coloplast A/S.