CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 89 enrolled
Drug / intervention
Endoscopic Retrograde Cholangio-Pancreatography (ERCP)device
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.

Search/NCT05129449
NCT05129449N/ACompleted
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Safety and Performance of the Motorized Spiral Endoscope PowerSpiral in Subjects Indicated for Small-bowel Enteroscopy or Endoscopic Retrograde Cholangio-Pancreatography (ERCP) in Subjects With Surgically Altered Gastrointestinal Anatomy.

Olympus Europe SE & Co. KG·observational·Posted Nov 22, 2021·Updated Mar 26, 2025

In Brief

An observational study evaluating Endoscopic Retrograde Cholangio-Pancreatography (ERCP) for Cholangiopancreatography, Endoscopic Retrograde. Completed, enrolled 89 participants across 5 sites in 3 countries.

Detailed Summary

The objective of the SAMISEN study phase B is to assess the performance and safety of diagnostic and therapeutic procedures with the Olympus Motorized Spiral Enteroscope (PowerSpiral) in subjects with surgically altered gastrointestinal anatomy indicated for an Endoscopic Retrograde Cholangio-Pancreatography (ERCP).

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsCholangiopancreatography, Endoscopic Retrograde
CountriesBelgium, Germany, Norway
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedNov 22, 2021
Enrollment StartJan 17, 2022
Primary CompletionJun 21, 2023
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 4.6 years ago

Interventions

Endoscopic Retrograde Cholangio-Pancreatography (ERCP)device

Endoscopic Retrograde Cholangio-Pancreatography (ERCP) conducted with motorized PowerSpiral in subjects presenting with surgically altered GI anatomy indicated for ERCP with biliary indication.