NCT03955081

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).

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
302

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Geographic Reach
6 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 17, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

September 2, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

January 30, 2024

Completed
Last Updated

January 30, 2024

Status Verified

August 1, 2020

Enrollment Period

1.6 years

First QC Date

February 1, 2019

Results QC Date

May 31, 2022

Last Update Submit

January 22, 2024

Conditions

Small Bowel Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Number of Participants With Therapeutic Yield

    up to 12 days

  • Number of Participants With Procedures That Confirmed Previous Diagnosis

    up to 12 days

Interventions

Deep enteroscopyDEVICE

A deep enteroscopy conducted with the new medical device PowerSpiral.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with an indication for direct visualization of the small bowel which fulfil all of these inclusion and exclusion criteria.

You may qualify if:

  • Signed informed consent
  • Patients with small bowel disease indicated for deep enteroscopy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Cliniques universitaires Saint-Luc ASBL

Brussels, Belgium

Location

Hôpital Erasme,

Brussels, Belgium

Location

Aarhus University Hospital

Aarhus N, Denmark

Location

Helsinki University Central Hospital

Helsinki, Finland

Location

Hospices Civils de Lyon, Hôpital Edouard Herriot

Lyon, France

Location

Evangelisches Krankenhaus Düsseldorf

Düsseldorf, Germany

Location

Universitätsklinikum Erlangen

Erlangen, Germany

Location

Klinikum rechts der Isar

Münich, Germany

Location

Sana Klinikum Offenbach GmbH

Offenbach, Germany

Location

OUS-Rikshospitalet University Hospital

Oslo, Norway

Location

Related Publications (1)

  • 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.

    PMID: 35451040DERIVED

Limitations and Caveats

Further evaluations of PowerSpiral in prospective studies in special indications like biliopancreatic interventions are needed.

Results Point of Contact

Title
Peter Teichmann, PhD
Organization
OLYMPUS EUROPA SE & CO. KG
peter.teichmann@olympus.com
+49 40 23773

Study Officials

  • Torsten Beyna, MD

    Evangelisches Kranken-haus Düssel-dorf

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
5 Days
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2019

First Posted

May 17, 2019

Study Start

September 2, 2019

Primary Completion

March 23, 2021

Study Completion

May 31, 2021

Last Updated

January 30, 2024

Results First Posted

January 30, 2024

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)DE(4)NO(1)FR(1)BE(2)FI(1)