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Clinical Trials/NCT03955081
NCT03955081CompletedNot Applicable

Safety and Performance of the Motorized Spiral Endoscope (PowerSpiral) in Subjects Indicated for Small-bowel Enteroscopy: A PMCF Registry

Olympus Europe SE & Co. KG10 sites in 6 countries302 target enrollmentStarted: September 2, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
302
Locations
10
Primary Endpoint
Collect Serious Adverse Events and Device Deficiencies to Demonstrate Safety of the Motorized Spiral Endoscope (PowerSpiral) in Daily Medical Practice.

Study Overview

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).

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 Design

Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Number of Participants With Therapeutic Yield(up to 12 days)
  • Number of Participants With Procedures That Confirmed Previous Diagnosis(up to 12 days)

Investigators

Sponsor
Olympus Europe SE & Co. KG
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (10)

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