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

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.

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).

Study Overview

• Status: Completed
• Conditions: Cholangiopancreatography, Endoscopic Retrograde
• Intervention / Treatment: Device: 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 Type: Observational
• Enrollment (Actual): 89

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium
    • Hôpital Erasme
  • Bruxelles, Belgium
    • Cliniques Universitaires Saint-luc
• Germany
  • Duesseldorf, Germany
    • Evangelisches Krankenhaus Düsseldorf
  • Frankfurt, Germany
    • University Hospital Frankfurt a.M.
• Norway
  • Oslo, Norway
    • OUS-Rikshospitalet University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects presenting with surgically altered GI anatomy indicated for ERCP with biliary indication, which fulfil all inclusion and none of the exclusion criteria.

Description

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 In addition to be eligible for study enrollment a subject must not meet any of the exclusion criteria listed below.

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Success Rate. Defined as the Combined Percentage of Enteroscopy Success Rate, Biliary Cannulation Success Rate and Procedural (Therapeutic) Success Rate.	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.	17 months.
Total Procedure Time	starting with oral insertion until final withdrawal of the device	Same day of the ERCP measurement.
Enteroscopy Time	starting with oral insertion until reaching the papilla or the biliary anastomosis	Same day of the ERCP measurement.
(Serious) Adverse Events and Device Deficiencies.	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	17 months.

Collaborators and Investigators

• Sponsor: Olympus Europe SE & Co. KG
• Investigators: Principal Investigator: Torsten Beyna, MD PhD, Evangelisches Kranken-haus Düssel-dorf; Principal Investigator: Tom G. Moreels, Prof., Cliniques Universitaires Saint-luc

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2022
• Primary Completion (Actual): June 21, 2023
• Study Completion (Actual): June 21, 2023

Study Registration Dates

• First Submitted: November 10, 2021
• First Submitted That Met QC Criteria: November 10, 2021
• First Posted (Actual): November 22, 2021

Study Record Updates

• Last Update Posted (Actual): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2018-GI (OEKG) - 01 Phase B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No