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Completed

NCT Number: NCT05129449

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

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).

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Key information

Conditions

Cholangiopancreatography, Endoscopic Retrograde

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cliniques universitaires Saint-Luc, Brussels, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Total Success Rate. Defined as the Combined Percentage of Enteroscopy Success Rate, Biliary Cannulation Success Rate and Procedural (Therapeutic) Success Rate.

    Time frame: 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.

  2. Total Procedure Time

    Time frame: Same day of the ERCP measurement.

    starting with oral insertion until final withdrawal of the device

  3. Enteroscopy Time

    Time frame: Same day of the ERCP measurement.

    starting with oral insertion until reaching the papilla or the biliary anastomosis

  4. (Serious) Adverse Events and Device Deficiencies.

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Olympus Europe SE & Co. KG

Industry

Registry information

Official study title

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.

Acronym: SAMISEN-B

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 22, 2021
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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