At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 3,017 enrolled
Drug / intervention
SenSuradevice
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.
An Open Label, Non-comparative, Multi-national Post-Market Study to Document Real Life Experience on SenSura With Focus on Skin Condition and Quality of Life
In Brief
A Phase 4 clinical trial evaluating SenSura for Stoma. Completed, enrolled 3,017 participants across 1 site.
Detailed Summary
The main purpose of the study is to document real life experience on SenSura with focus on skin condition and quality of life.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStoma
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2008
First PostedFeb 2008
Primary CompletionApr 2010
Study CompletionDec 2010
TodayJul 2026
First PostedFeb 29, 2008
Enrollment StartFeb 1, 2008
Primary CompletionApr 1, 2010
Study CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 18.3 years ago
Interventions
SenSuradevice
Real life assessment of SenSura