Cholangiopancreatography, Endoscopic RetrogradeSAMISEN-BNCT05129449
A Clinical Study With the Medical Device PowerSpiral for Endoscopic Retrograde Cholangio-Pancreatography (ERCP)
An observational study of Cholangiopancreatography, Endoscopic Retrograde, run by Olympus Europe SE & Co. KG at 5 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cholangiopancreatography, Endoscopic Retrograde
- What is being tested?
- Endoscopic Retrograde Cholangio-Pancreatography (ERCP)
- Type of treatment
- Medical device
- How many people
- 89 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 17 Jan 2022to 21 Jun 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Belgium2 sites
Cliniques universitaires Saint-Luc
Brussels
Hôpital Erasme
Brussels
Germany2 sites
Evangelisches Krankenhaus Düsseldorf
Düsseldorf
University Hospital Frankfurt a.M.
Frankfurt
About this study
Official 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.
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).
Read the 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.
- Being tested
- Endoscopic Retrograde Cholangio-Pancreatography (ERCP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 17 months.
Total Procedure Time
starting with oral insertion until final withdrawal of the device
Measured: Same day of the ERCP measurement.
Enteroscopy Time
starting with oral insertion until reaching the papilla or the biliary anastomosis
Measured: 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
Measured: 17 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start17 Jan 2022
- Primary completion21 Jun 2023
- Study completion21 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cholangiopancreatography, Endoscopic RetrogradeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olympus Europe SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Torsten Beyna, MD PhD, Principal investigator, Evangelisches Kranken-haus Düssel-dorfTom G. Moreels, Prof., Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129449
- Sponsor's protocol ID
- 2018-GI (OEKG) - 01 Phase B
- Acronym
- SAMISEN-B
- Status last verified
- Jul 2024
- First submitted
- 10 Nov 2021
- Last updated
- 26 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39610946
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT05129449
- Acronym / sponsor ID
- SAMISEN-B / 2018-GI (OEKG) - 01 Phase B
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Olympus Europe SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- 21 Jun 2023 (actual)
- Study completion
- 21 Jun 2023 (actual)
- First posted
- 22 Nov 2021 (actual)
- Results
- Posted 26 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic Retrograde Cholangio-Pancreatography (ERCP)Endoscopic Retrograde Cholangio-Pancreatography (ERCP) conducted with motorized PowerSpiral in subjects presenting with surgically altered GI anatomy indicated for ERCP with biliary indication. | Device | – |
Primary outcome
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.
Total Procedure Time
Time frame: Same day of the ERCP measurement.
starting with oral insertion until final withdrawal of the device
Enteroscopy Time
Time frame: Same day of the ERCP measurement.
starting with oral insertion until reaching the papilla or the biliary anastomosis
(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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39610946Moreels 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Torsten Beyna, MD PhD principal investigator
Evangelisches Kranken-haus Düssel-dorf
Tom G. Moreels, Prof. principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholangiopancreatography, Endoscopic Retrograde, run by Olympus Europe SE & Co. KG at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium, Germany, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05129449, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.