At a glance
ClinicalIndex Comparison RecordN/ACompleted· 130 enrolled
Drug / intervention
Coloplast test product +1 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 a New 2-piece Ostomy Product Compared With SenSura Click in 130 Subjects With an Ileostomy.
In Brief
A clinical study evaluating Coloplast test product and SenSura for Ileostomy - Stoma. Completed, enrolled 130 participants across 17 sites in 5 countries.
Detailed Summary
The aim of the current investigation is to investigate the performance of a new 2-piece ostomy product
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIleostomy - Stoma
CountriesBelgium, Denmark, Netherlands, Norway, Sweden
Collaborators--
Timeline
N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartSep 2013
First PostedOct 2013
Primary CompletionDec 2013
TodayJul 2026
First PostedOct 8, 2013
Enrollment StartSep 1, 2013
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 12.7 years ago
Interventions
Coloplast test productdevice
Coloplast test product is a newly developed 2-piece ostomy appliance
SenSuradevice
SenSura is the commercial available CE-marked SenSura Click 2-piece ostomy appliance from Coloplast A/S