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A Clinical Study With the Medical Device PowerSpiral for Endoscopic Retrograde Cholangio-Pancreatography (ERCP) — SAMISEN-B  

Cholangiopancreatography, Endoscopic Retrograde Clinical Trial

Official title:
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.

Clinical Trial 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).

Clinical Trial Description

The main objective of this registry is to collect data on the safety and performance of the motorized PowerSpiral device during Post-market Clinical Follow-up in subjects with surgically altered gastrointestinal anatomy indicated for an Endoscopic Retrograde Cholangio-Pancreatography (ERCP). It is assumed that this motorized PowerSpiral device and its safety profile is non-inferior to preceding generations of balloon assisted enteroscopes. As clinical performance and efficacy is equally important for the user this study also collects efficacy and handling data of the motorized PowerSpiral device. ;

Study Design

Related Conditions & MeSH terms

  • Cholangiopancreatography, Endoscopic Retrograde
Clinical Trial Details
NCT number NCT05129449
Study type Observational
Source Olympus Europe SE & Co. KG
Contact
Status Terminated
Phase
Start date January 17, 2022
Completion date June 21, 2023
View Details
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