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

NCT05129449 | Completed Results

• 1 other identifier: 2018-GI (OEKG) - 01 Phase B
• Study Type: observational
• Target: 89
• Locations: 3 countries
• Sites: 5

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).

Conditions

Cholangiopancreatography, Endoscopic Retrograde

Outcome Measures

Primary Outcomes (4)

• 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.

Interventions

Endoscopic Retrograde Cholangio-Pancreatography (ERCP) DEVICE

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Signed informed consent
• 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.

You may not qualify if:

• Age under 18 years
• Female and of child-bearing age who is currently pregnant or planning to become pregnant within the study period
• 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
• Concurrent participation in another competing clinical study
• Pancreatic indication for ERCP in patient with surgically altered anatomy

Sponsors & Collaborators

• Olympus Europe SE & Co. KG: lead

Study Sites (5)

Cliniques universitaires Saint-Luc

Brussels, Belgium

Location

Hôpital Erasme

Brussels, Belgium

Location

Evangelisches Krankenhaus Düsseldorf

Düsseldorf, Germany

Location

University Hospital Frankfurt a.M.

Frankfurt, Germany

Location

OUS-Rikshospitalet University Hospital

Oslo, Norway

Location

Related Publications (1)

• Moreels TG, Aabakken L, Arvanitaki M, Knabe M, Beyna T. Enteroscopy-assisted ERCP in patients with surgically altered anatomy: Multicenter prospective registry (SAMISEN-B) using motorized spiral enteroscopy. Endosc Int Open. 2024 Nov 28;12(11):E1392-E1400. doi: 10.1055/a-2443-1514. eCollection 2024 Nov.

  PMID: 39610946 DERIVED

Results Point of Contact

• Title: Dr. Peter Teichmann
• Organization: OLYMPUS EUROPA SE & CO. KG

peter.teichmann@olympus.com

+49 40 23773

Study Officials

• Torsten Beyna, MD PhD

  Evangelisches Kranken-haus Düssel-dorf

  PRINCIPAL INVESTIGATOR

• Tom G. Moreels, Prof.

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: November 22, 2021
• Study Start: January 17, 2022
• Primary Completion: June 21, 2023
• Study Completion: June 21, 2023
• Last Updated: March 26, 2025
• Results First Posted: March 26, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); BE (2); NO (1)