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A Clinical Study With the Medical Device PowerSpiral for Deep Enteroscopy (SAMISEN)

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ClinicalTrials.gov Identifier: NCT03955081
Recruitment Status : Not yet recruiting
First Posted : May 17, 2019
Last Update Posted : June 10, 2019
Sponsor:
Information provided by (Responsible Party):
Olympus Europe SE & Co. KG

Brief 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).

Condition or disease Intervention/treatment
Small Bowel Disease Device: Deep enteroscopy

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 335 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 5 Days
Official Title: Safety and Performance of the Motorized Spiral Endoscope (PowerSpiral) in Subjects Indicated for Small-bowel Enteroscopy: A PMCF Registry
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Intervention Details:
  • Device: Deep enteroscopy
    A deep enteroscopy conducted with the new medical device PowerSpiral.


Primary Outcome Measures :
  1. 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. Diagnostic Yield [ Time Frame: up to 12 days ]
    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.

  3. Therapeutic Yield [ Time Frame: up to 12 days ]
    Defined as the percentage of patients with any endoscopic intervention / therapy with the exception of biopsies.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with an indication for direct visualization of the small bowel which fulfil all of these inclusion and exclusion criteria.
Criteria

Inclusion Criteria:

  1. Signed informed consent
  2. Patients with small bowel disease indicated for deep enteroscopy

Exclusion Criteria:

  1. Age under 18 years
  2. Female and of child-bearing age who is currently pregnant or planning to become pregnant within the study period
  3. Any contraindication to standard enteroscopy
  4. Concurrent participation in another competing clinical study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03955081


Contacts
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Contact: Peter Teichmann, PhD +49 40 23773-0 ext -7835 peter.teichmann@olympus-europa.com

Locations
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Belgium
Hôpital Erasme, Not yet recruiting
Brussels, Belgium
Contact: NA NA         
Denmark
Aarhus University Hospital Not yet recruiting
Aarhus N, Denmark
Contact: NA NA         
Finland
Helsinki University Central Hospital Not yet recruiting
Helsinki, Finland
Contact: NA NA         
France
Hospices Civils de Lyon, Hôpital Edouard Herriot Not yet recruiting
Lyon, France
Contact: NA NA         
Germany
Evangelisches Krankenhaus Düsseldorf Not yet recruiting
Duesseldorf, Germany
Contact: Torsten Beyna, MD PhD         
Universitätsklinikum Erlangen Not yet recruiting
Erlangen, Germany
Contact: NA NA         
Klinikum rechts der Isar Not yet recruiting
Münich, Germany
Contact: NA NA         
Sana Klinikum Offenbach GmbH Not yet recruiting
Offenbach, Germany
Contact: NA NA         
Italy
Università Cattolica del Sacro Cuore Not yet recruiting
Rom, Italy
Contact: NA NA         
University Division of Gastroenterology
Torino, Italy
Netherlands
Amsterdam UMC Universitair Medische Centre Not yet recruiting
Amsterdam, Netherlands
Contact: NA NA         
Norway
OUS-Rikshospitalet University Hospital Not yet recruiting
Oslo, Norway
Contact: NA NA         
Sponsors and Collaborators
Olympus Europe SE & Co. KG
Investigators
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Principal Investigator: Torsten Beyna, MD Evangelisches Kranken-haus Düssel-dorf

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Responsible Party: Olympus Europe SE & Co. KG
ClinicalTrials.gov Identifier: NCT03955081     History of Changes
Other Study ID Numbers: 2018-GI (OEKG) - 01
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No