At a glance
ClinicalIndex Comparison RecordN/ACompleted· 183 enrolled
Drug / intervention
Coloplast Test Product 1 +2 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 Two New 1-piece Ostomy Products in 180 Subjects With Ileostomy
In Brief
A clinical study evaluating Coloplast Test Product 1, Coloplast Test Product 2, and 1 other intervention for Ileostomy - Stoma. Completed, enrolled 183 participants across 4 sites in 4 countries.
Detailed Summary
The aim of the current investigation is to investigate the performance of two new 1-piece ostomy products
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIleostomy - Stoma
CountriesDenmark, Netherlands, Norway, United Kingdom
Collaborators--
Timeline
N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJul 2013
Primary CompletionSep 2013
First PostedOct 2013
TodayJul 2026
First PostedOct 8, 2013
Enrollment StartJul 1, 2013
Primary CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 12.7 years ago
Interventions
Coloplast Test Product 1device
Coloplast Test product 1 is a newly developed 1-piece ostomy appliance
Coloplast Test Product 2device
Coloplast Test product 2 is a newly developed 1-piece ostomy appliance
Coloplast SenSuradevice
SenSura 1-piece is the commercial available CE-marked SenSura 1-piece from Coloplast A/S.