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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).
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 17 months. |
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Inclusion criteria
Exclusion criteria In addition to be eligible for study enrollment a subject must not meet any of the exclusion criteria listed below.
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Subjects presenting with surgically altered GI anatomy indicated for ERCP with biliary indication, which fulfil all inclusion and none of the exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques universitaires Saint-Luc | Brussels | Belgium | ||||
| Hôpital Erasme |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39610946 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm Study | All patients received an ERCP examining with the CE- marked PowerSpiral (OLYMPUS PSF-1, SINGLE USE POWER SPIRAL TUBE and motor control unit POWER SPIRAL CONTROL) device. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Jun 28, 2021 | Nov 6, 2024 |
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| Brussels |
| Belgium |
| Evangelisches Krankenhaus Düsseldorf | Düsseldorf | Germany |
| University Hospital Frankfurt a.M. | Frankfurt | Germany |
| OUS-Rikshospitalet University Hospital | Oslo | Norway |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm Study | All patients received an ERCP examining with the CE- marked PowerSpiral (OLYMPUS PSF-1, SINGLE USE POWER SPIRAL TUBE and motor control unit POWER SPIRAL CONTROL) device. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | 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. | Posted | Count of Participants | Participants | 17 months. |
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| Primary | Total Procedure Time | starting with oral insertion until final withdrawal of the device | Posted | Mean | Standard Deviation | Minutes | Same day of the ERCP measurement. |
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| Primary | Enteroscopy Time | starting with oral insertion until reaching the papilla or the biliary anastomosis | Posted | Mean | Standard Deviation | Minutes | Same day of the ERCP measurement. |
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| Primary | (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:
| Posted | Count of Participants | Participants | 17 months. |
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17 months
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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 Study | All patients received an ERCP examining with the CE- marked PowerSpiral (OLYMPUS PSF-1, SINGLE USE POWER SPIRAL TUBE and motor control unit POWER SPIRAL CONTROL) device. | 0 | 88 | 6 | 88 | 6 | 88 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding | Gastrointestinal disorders | Systematic Assessment |
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| Cholangitis | Hepatobiliary disorders | Systematic Assessment |
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| Perforation | Gastrointestinal disorders | Systematic Assessment |
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| Suspected pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding | Gastrointestinal disorders | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | Systematic Assessment |
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| Other (System malfunction, non-rotation of spiral before start.) | Product Issues | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter Teichmann | OLYMPUS EUROPA SE & CO. KG | +49 40 23773 | 7835 | peter.teichmann@olympus.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 8, 2023 | Nov 6, 2024 | SAP_001.pdf |
| >=65 years |
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| Germany |
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