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

Completed

• Conditions: Cholangiopancreatography, Endoscopic Retrograde

• Registration Number: NCT05129449
• Lead Sponsor: Olympus Europe SE & Co. KG

Brief 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.

Study Timeline

• Study First Submitted: 2021-11-10
• Study First Submitted QC: 2021-11-10
• Study First Posted: 2021-11-22
• Study Start: 2022-01-17
• Primary Completion: 2023-06-21
• Study Completion: 2023-06-21
• Status Verified: 2024-07
• Results First Submitted: 2024-07-05
• Results First Submitted QC: 2025-03-17
• Last Update Submitted: 2025-03-17
• Results First Posted: 2025-03-26
• Last Update Posted: 2025-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total Success Rate. Defined as the Combined Percentage of Enteroscopy Success Rate, Biliary Cannulation Success Rate and Procedural (Therapeutic) Success Rate.	17 months.	The total success rate refer to the percentage of the following succes rates relevant for ERCP procedures. Combined percentage of Enteroscopy success rate, Biliary Cannulation success rate and Procedural (Therapeutic) success rate.
Total Procedure Time	Same day of the ERCP measurement.	starting with oral insertion until final withdrawal of the device
Enteroscopy Time	Same day of the ERCP measurement.	starting with oral insertion until reaching the papilla or the biliary anastomosis
(Serious) Adverse Events and Device Deficiencies.	17 months.	Incidence (% of subjects) and frequency (no. of subjects) with Serious Adverse Events (SAEs) and Device Deficiencies (DD) which meet the severity grading of moderate or severe for the following categories: * Enteroscopy-associated complications (mainly bleeding and perforation(s)); * ERCP-related complications (Dumonceau et al. 2020); * Sedation / anesthesia related complications; * other

Trial Locations

Locations (5)

OUS-Rikshospitalet University Hospital; 🇳🇴 Oslo, Norway

Hôpital Erasme; 🇧🇪 Brussels, Belgium

University Hospital Frankfurt a.M.; 🇩🇪 Frankfurt, Germany

Evangelisches Krankenhaus Düsseldorf; 🇩🇪 Duesseldorf, Germany

Cliniques universitaires Saint-Luc; 🇧🇪 Bruxelles, Belgium