At a glance
ClinicalIndex Comparison RecordN/ACompleted· 302 enrolled
Drug / intervention
Deep enteroscopydevice
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.
Safety and Performance of the Motorized Spiral Endoscope (PowerSpiral) in Subjects Indicated for Small-bowel Enteroscopy: A PMCF Registry
In Brief
An observational study evaluating Deep enteroscopy for Small Bowel Disease. Completed, enrolled 302 participants across 10 sites in 6 countries.
Detailed Summary
The objective of the SAMISEN study is to assess the performance and safety of diagnostic and therapeutic procedures with the newly designed Olympus Motorized Spiral Enteroscope (PowerSpiral).
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsSmall Bowel Disease
CountriesBelgium, Denmark, Finland, France, Germany, Norway
Collaborators--
Timeline
N/ACompletedFinished
2020202120222023202420252026
First PostedMay 2019
Enrollment StartSep 2019
Primary CompletionMar 2021
Study CompletionMay 2021
TodayJul 2026
First PostedMay 17, 2019
Enrollment StartSep 2, 2019
Primary CompletionMar 23, 2021
Study CompletionMay 31, 2021
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 7.1 years ago
Interventions
Deep enteroscopydevice
A deep enteroscopy conducted with the new medical device PowerSpiral.