At a glance
ClinicalIndex Comparison RecordN/ACompleted· 129 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.
Investigation of Newly Developed 1-and 2-piece Convex Ostomy Products in Subjects With Ileostomy.
In Brief
A clinical study evaluating Coloplast test product and SenSura Convex Light for Stoma Ileostomy. Completed, enrolled 129 participants across 29 sites in 5 countries.
Detailed Summary
The aim of the investigation was to investigate the performance and safety of a new ostomy product.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStoma Ileostomy
CountriesDenmark, France, Germany, Norway, United Kingdom
Collaborators--
Timeline
N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartNov 2013
First PostedNov 2013
Primary CompletionJun 2014
TodayJul 2026
First PostedNov 26, 2013
Enrollment StartNov 1, 2013
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 12.6 years ago
Interventions
Coloplast test productdevice
The Coloplast test product is a newly developed ostomy appliance
SenSura Convex Lightdevice
The comparator product is SenSura Convex Light, which is CE-marked and commercially available.