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A Clinical Study With the Medical Device PowerSpiral for Deep Enteroscopy — SAMISEN  

Small Bowel Disease Clinical Trial

Official title:
Safety and Performance of the Motorized Spiral Endoscope (PowerSpiral) in Subjects Indicated for Small-bowel Enteroscopy: A PMCF Registry

Clinical Trial 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).

Clinical Trial Description

The main objective of this registry is to collect data on the safety and performance of the new motorized PowerSpiral device during Post-market Clinical Follow-up. It is assumed that the new 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 new device. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03955081
Study type Observational [Patient Registry]
Source Olympus Europe SE & Co. KG
Contact
Status Completed
Phase
Start date September 2, 2019
Completion date May 31, 2021
View Details
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