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

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.

NCT05129449•Olympus Europe SE & Co. KG

View on ClinicalTrials.gov

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).

Detailed 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.

Eligibility

Age

18 - 90 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Signed informed consent
•2. Patients with surgically altered upper Gastrointestinal anatomy (Roux-en-Y and Billroth II types) with a biliary indication for ERCP where access with conventional ERCP devices is of no avail and after careful risk assessment.

Exclusion Criteria

•1. Age under 18 years
•2. Female and of child-bearing age who is currently pregnant or planning to become pregnant within the study period
•3. Any contraindication to standard enteroscopy or ERCP (e.g. severe coagulopathy or known coagulation disorder; bowel obstruction / stenosis, stents or other instruments implanted in the intestinal tract, suspected GI perforation, esophageal or gastric varices, eosinophilic esophagitis) as judged by the investigator after careful individual risk assessment
•4. Concurrent participation in another competing clinical study
•5. Pancreatic indication for ERCP in patient with surgically altered anatomy

Locations (5)

Cliniques universitaires Saint-Luc

Brussels, Belgium

Hôpital Erasme

Brussels, Belgium

Evangelisches Krankenhaus Düsseldorf

Düsseldorf, Germany

University Hospital Frankfurt a.M.

Frankfurt, Germany

OUS-Rikshospitalet University Hospital

Oslo, Norway

Key Dates

Start Date

January 17, 2022

Primary Completion Date

June 21, 2023

Completion Date

June 21, 2023

Last Updated

March 26, 2025

Enrollment

ACTUAL participants

Conditions

Cholangiopancreatography, Endoscopic Retrograde

Interventions

Endoscopic Retrograde Cholangio-Pancreatography (ERCP)

DEVICE

Prospective Evaluation of Biliary Tissue Sampling with ERCP

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ACTIVE_NOT_RECRUITINGNA

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Jaundice, ObstructiveCholangiopancreatography, Endoscopic Retrograde+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 26, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Prospective Evaluation of Biliary Tissue Sampling with ERCP

A RCT of Low MBO Drainage Strategies

Prevalence of Multidrug Resistant Micro-organism Carriage in Patients Undergoing an ERCP in Four Different Countries

ERCP and LC for Cholecystocholedocholithiasis in Children: Should It Be Accomplished in One or Repeated Hospitalization?

The Optimal Dose of Indomethacin Suppository for Preventing Post-ERCP Pancreatitis

Evaluation of "PreCut-Papillectomy" in Difficult Biliary Cannulation