At a glance
ClinicalIndex Comparison RecordN/ACompleted· 51 enrolled
Drug / intervention
New 2-piece Coupling +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.
A Randomized, Controlled Clinical Investigation of an Improved Two-piece Stoma Product for People Living With a Stoma
In Brief
A clinical study evaluating New 2-piece Coupling and SenSura Mio Click for Surgical Stomas. Completed, enrolled 51 participants across 1 site.
Detailed Summary
Open-label, randomized, controlled, comparative, cross-over study with 2 test sequences comparing a new 2-piece coupling system with SenSura Mio Click.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSurgical Stomas
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2023202420252026
First PostedDec 2022
Enrollment StartFeb 2023
Primary CompletionJul 2023
TodayJul 2026
First PostedDec 15, 2022
Enrollment StartFeb 15, 2023
Primary CompletionJul 15, 2023
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 3.5 years ago
Interventions
New 2-piece Couplingdevice
Flat or concave baseplate. SenSura Mio Click maxi bag (open, wide outlet) with new 50mm Ø coupling.
SenSura Mio Clickdevice
Flat or concave baseplate. SenSura Mio Click maxi bag (open, wide outlet) with 50mm Ø coupling.