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

NCT05129449 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 89

Last updated 2025-03-26

Study results available
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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).

Conditions

  • Cholangiopancreatography, Endoscopic Retrograde

Interventions

DEVICE

Endoscopic Retrograde Cholangio-Pancreatography (ERCP)

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

Sponsors & Collaborators

  • Olympus Europe SE & Co. KG

    lead INDUSTRY

Principal Investigators

  • Torsten Beyna, MD PhD · Evangelisches Kranken-haus Düssel-dorf

  • Tom G. Moreels, Prof. · Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-17
Primary Completion
2023-06-21
Completion
2023-06-21

Countries

  • Belgium
  • Germany
  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05129449 on ClinicalTrials.gov