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

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).

Study Overview

• Status: Completed
• Conditions: Small Bowel Disease
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 302

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium
    • Hôpital Erasme,
  • Bruxelles, Belgium
    • Cliniques Universitaires Saint-Luc ASBL
• Denmark
  • Aarhus N, Denmark
    • Aarhus University Hospital
• Finland
  • Helsinki, Finland
    • Helsinki University Central Hospital
• France
  • Lyon, France
    • Hospices Civils de Lyon, Hôpital Edouard Herriot
• Germany
  • Duesseldorf, Germany
    • Evangelisches Krankenhaus Düsseldorf
  • Erlangen, Germany
    • Universitätsklinikum Erlangen
  • Münich, Germany
    • Klinikum Rechts der Isar
  • Offenbach, Germany
    • Sana Klinikum Offenbach GmbH
• Norway
  • Oslo, Norway
    • OUS-Rikshospitalet University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 86 years (Adult, Older Adult)
• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Olympus Europe SE & Co. KG
• Investigators: Principal Investigator: Torsten Beyna, MD, Evangelisches Kranken-haus Düssel-dorf

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2019
• Primary Completion (Actual): March 23, 2021
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: February 1, 2019
• First Submitted That Met QC Criteria: May 16, 2019
• First Posted (Actual): May 17, 2019

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases
• Other Study ID Numbers: 2018-GI (OEKG) - 01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No