Trials / Completed
CompletedNCT03955081
A Clinical Study With the Medical Device PowerSpiral for Deep Enteroscopy
Safety and Performance of the Motorized Spiral Endoscope (PowerSpiral) in Subjects Indicated for Small-bowel Enteroscopy: A PMCF Registry
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 302 (actual)
- Sponsor
- Olympus Europe SE & Co. KG · Industry
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Deep enteroscopy | A deep enteroscopy conducted with the new medical device PowerSpiral. |
Timeline
- Start date
- 2019-09-02
- Primary completion
- 2021-03-23
- Completion
- 2021-05-31
- First posted
- 2019-05-17
- Last updated
- 2024-01-30
- Results posted
- 2024-01-30
Locations
10 sites across 6 countries: Belgium, Denmark, Finland, France, Germany, Norway
Source: ClinicalTrials.gov record NCT03955081. Inclusion in this directory is not an endorsement.