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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).
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep enteroscopy | Device | A deep enteroscopy conducted with the new medical device PowerSpiral. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 12 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Therapeutic Yield | Defined as the percentage of patients with any endoscopic intervention / therapy with the exception of biopsies. | up to 12 days |
| Number of Participants With Procedures That Confirmed Previous Diagnosis |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with an indication for direct visualization of the small bowel which fulfil all of these inclusion and exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Torsten Beyna, MD | Evangelisches Kranken-haus Düssel-dorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques universitaires Saint-Luc ASBL | Brussels | Belgium | ||||
| Hôpital Erasme, |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35451040 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm | Patients who received at least one procedure with the Motorized Spiral Endoscope (PowerSpiral). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
302 patient were enrolled, however 4 patients excluded because there was no deep enteroscopy conducted. So that 298 patients were analyzed according SAP.
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm | Patients who received at least one procedure with the Motorized Spiral Endoscope (PowerSpiral). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | SAE rate | Posted | Number | participants | up to 12 days |
|
|
Adverse events were collected during the whole study duration of approx. 18 months and for each individual patients from signing the consent until hospital discharge.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm | Patients who received at least one procedure with the Motorized Spiral Endoscope (PowerSpiral). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Perforation | Gastrointestinal disorders | IMDRF | Non-systematic Assessment | SAE occurred during the first procedure with PowerSpiral. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding | Gastrointestinal disorders | IMDRF | Non-systematic Assessment | First procedure with PowerSpiral |
Further evaluations of PowerSpiral in prospective studies in special indications like biliopancreatic interventions are needed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Teichmann, PhD | OLYMPUS EUROPA SE & CO. KG | +49 40 23773 | 7835 | peter.teichmann@olympus.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 23, 2019 | May 31, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 25, 2021 | May 31, 2022 | SAP_001.pdf |
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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.
| up to 12 days |
| Brussels |
| Belgium |
| Aarhus University Hospital | Aarhus N | Denmark |
| Helsinki University Central Hospital | Helsinki | Finland |
| Hospices Civils de Lyon, Hôpital Edouard Herriot | Lyon | France |
| Evangelisches Krankenhaus Düsseldorf | Düsseldorf | Germany |
| Universitätsklinikum Erlangen | Erlangen | Germany |
| Klinikum rechts der Isar | Münich | Germany |
| Sana Klinikum Offenbach GmbH | Offenbach | Germany |
| OUS-Rikshospitalet University Hospital | Oslo | Norway |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Participants |
|
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| Secondary | Number of Participants With Therapeutic Yield | Defined as the percentage of patients with any endoscopic intervention / therapy with the exception of biopsies. | Posted | Count of Participants | Participants | up to 12 days |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | up to 12 days |
|
|
|
| 7 |
| 298 |
| 7 |
| 298 |
| 9 |
| 298 |
|
| Bleeding | Gastrointestinal disorders | IMDRF | Non-systematic Assessment | SAE occurred during the first and second procedure with PowerSpiral. |
|
| Mucosal injury | Gastrointestinal disorders | IMDRF | Non-systematic Assessment | First procedure with PowerSpiral |
|
| Complications associated with sedation/anesthesia | General disorders | IMDRF | Non-systematic Assessment | First and second procedure with PowerSpiral |
|
| Other | Gastrointestinal disorders | IMDRF | Non-systematic Assessment | First procedure with PowerSpiral |
|
|
| Laceration | Gastrointestinal disorders | IMDRF | Non-systematic Assessment | First and second procedure with PowerSpiral |
|
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