Small Bowel DiseaseSAMISENNCT03955081
A Clinical Study With the Medical Device PowerSpiral for Deep Enteroscopy
An observational study of Small Bowel Disease, run by Olympus Europe SE & Co. KG at 10 sites in 6 countries.
Trial summary
The objective of the SAMISEN study is to assess the performance and safety of diagnostic and therapeutic procedures with the newly designed Olympus Motorized Spiral Enteroscope (PowerSpiral). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Small Bowel Disease
- What is being tested?
- Deep enteroscopy
- Type of treatment
- Medical device
- How many people
- 302 participants
- Where
- 10 sitesin 6 countries
- Study dates
- 2 Sep 2019to 31 May 2021
- How long will I take part?
- 5 Days
- 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 with an indication for direct visualization of the small bowel which fulfil all of these inclusion and exclusion criteria.
Who may be able to join
- Signed informed consent
- Patients with small bowel disease indicated for deep enteroscopy
Who cannot join
- 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
- Concurrent participation in another competing clinical study
Trial locations and contacts
10 sites in 6 countries.
10 sites in 6 countries
Germany4 sites
Evangelisches Krankenhaus Düsseldorf
Düsseldorf
Universitätsklinikum Erlangen
Erlangen
Klinikum rechts der Isar
Münich
Sana Klinikum Offenbach GmbH
Offenbach
Belgium2 sites
Cliniques universitaires Saint-Luc ASBL
Brussels
Hôpital Erasme,
Brussels
About this study
Official title: Safety and Performance of the Motorized Spiral Endoscope (PowerSpiral) in Subjects Indicated for Small-bowel Enteroscopy: A PMCF Registry
The objective of the SAMISEN study is to assess the performance and safety of diagnostic and therapeutic procedures with the newly designed Olympus Motorized Spiral Enteroscope (PowerSpiral).
Read the detailed description
The main objective of this registry is to collect data on the safety and performance of the new motorized PowerSpiral device during Post-market Clinical Follow-up. It is assumed that the new 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 new device.
- Conditions
- Small Bowel Disease
- Being tested
- Deep enteroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep enteroscopyDevice
A deep enteroscopy conducted with the new medical device PowerSpiral.
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect Serious Adverse Events and Device Deficiencies to Demonstrate Safety of the Motorized Spiral Endoscope (PowerSpiral) in Daily Medical Practice.
It is assumed that the new device and its safety profile is non-inferior to preceding generations of balloon assisted enteroscopes. Endoscope (PowerSpiral) in a typical clinical setting within the Intended Use
Measured: up to 12 days
Secondary outcomes (2)
Number of Participants With Therapeutic Yield
Defined as the percentage of patients with any endoscopic intervention / therapy with the exception of biopsies.
Measured: up to 12 days
Number of Participants With Procedures That Confirmed Previous Diagnosis
Defined as the percentage of procedures that either confirmed a diagnosis from previous studies, or established a new definitive diagnosis at the anatomical location identified in previous studies or findings that could explain the clinical symptoms.
Measured: up to 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start2 Sep 2019
- Primary completion23 Mar 2021
- Study completion31 May 2021
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 Small Bowel DiseaseStudies 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
- 302 participants (actual)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- Olympus Europe SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Torsten Beyna, MD, Principal investigator, Evangelisches Kranken-haus Düssel-dorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03955081
- Sponsor's protocol ID
- 2018-GI (OEKG) - 01
- Acronym
- SAMISEN
- Status last verified
- Aug 2020
- First submitted
- 1 Feb 2019
- Last updated
- 30 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beyna T, Moreels T, Arvanitakis M, Pioche M, Saurin JC, May A, Knabe M, Agnholt JS, Bjerregaard NC, Puustinen L, Schlag C, Aabakken L, Paulsen V, Schneider M, Neurath MF, Rath T, Deviere J, Neuhaus H. Motorized spiral enteroscopy: results of an international multicenter prospective observational clinical study in patients with normal and altered gastrointestinal anatomy. Endoscopy. 2022 Dec;54(12):1147-1155. doi: 10.1055/a-1831-6215. Epub 2022 Apr 21.
PubMed 35451040
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. 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: A PMCF Registry
- ClinicalTrials.gov ID
- NCT03955081
- Acronym / sponsor ID
- SAMISEN / 2018-GI (OEKG) - 01
- Conditions
- Small Bowel Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Olympus Europe SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- 2 Sep 2019 (actual)
- Primary completion
- 23 Mar 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 17 May 2019 (actual)
- Results
- Posted 30 Jan 2024
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 is to assess the performance and safety of diagnostic and therapeutic procedures with the newly designed Olympus Motorized Spiral Enteroscope (PowerSpiral).
Detailed description
The main objective of this registry is to collect data on the safety and performance of the new motorized PowerSpiral device during Post-market Clinical Follow-up. It is assumed that the new 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 new device.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Days
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with an indication for direct visualization of the small bowel which fulfil all of these inclusion and exclusion criteria.
Key inclusion criteria (2 listed)
- Signed informed consent
- Patients with small bowel disease indicated for deep enteroscopy
Key exclusion criteria (4 listed)
- 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
- Concurrent participation in another competing clinical study
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 |
|---|---|---|
| Deep enteroscopyA deep enteroscopy conducted with the new medical device PowerSpiral. | Device | – |
Primary outcome
Collect Serious Adverse Events and Device Deficiencies to Demonstrate Safety of the Motorized Spiral Endoscope (PowerSpiral) in Daily Medical Practice.
Time frame: up to 12 days
It is assumed that the new device and its safety profile is non-inferior to preceding generations of balloon assisted enteroscopes. Endoscope (PowerSpiral) in a typical clinical setting within the Intended Use
2 secondary outcomes
Number of Participants With Therapeutic Yield
Time frame: up to 12 days
Number of Participants With Procedures That Confirmed Previous Diagnosis
Time frame: up to 12 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35451040Beyna T, Moreels T, Arvanitakis M, Pioche M, Saurin JC, May A, Knabe M, Agnholt JS, Bjerregaard NC, Puustinen L, Schlag C, Aabakken L, Paulsen V, Schneider M, Neurath MF, Rath T, Deviere J, Neuhaus H. Motorized spiral enteroscopy: results of an international multicenter prospective observational clinical study in patients with normal and altered gastrointestinal anatomy. Endoscopy. 2022 Dec;54(12):1147-1155. doi: 10.1055/a-1831-6215. Epub 2022 Apr 21.
- 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 principal investigator
Evangelisches Kranken-haus Düssel-dorf
10 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Small Bowel Disease, run by Olympus Europe SE & Co. KG at 10 sites in 6 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 2 inclusion and 4 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 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Belgium, Denmark, Finland, France and 1 more country. 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 30 Jan 2024). 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?
Collect Serious Adverse Events and Device Deficiencies to Demonstrate Safety of the Motorized Spiral Endoscope (PowerSpiral) in Daily Medical Practice. (time frame: up to 12 days). 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 NCT03955081, 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 30 Jan 2024.