At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 56 enrolled
Drug / intervention
SS +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.
Cross-over, Open Label Study Evaluating a New Ostomy Appliance With Regard to Leakage, Handling and Comfort
In Brief
A Phase 3 clinical trial evaluating SS and SenSura for Colostomy. Completed, enrolled 56 participants across 1 site.
Detailed Summary
The objective of this investigation is to evaluate leakage, handling and comfort of a new ostomy appliance compared to SenSura.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColostomy
CountriesDenmark
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2010
Primary CompletionNov 2010
First PostedNov 2010
TodayJul 2026
First PostedNov 18, 2010
Enrollment StartAug 1, 2010
Primary CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 15.6 years ago
Interventions
SSdevice
New ostomy appliance (SS) is tested in 10 ± 2 days and the degree of leakage under the baseplate is measured and compared to SenSura.
SenSuradevice
New ostomy appliance (SS) is tested in 10 ± 2 days and the degree of leakage under the baseplate is measured and compared to SenSura.