Trials / Completed
CompletedNCT05129449
A Clinical Study With the Medical Device PowerSpiral for Endoscopic Retrograde Cholangio-Pancreatography (ERCP)
Safety and Performance of the Motorized Spiral Endoscope PowerSpiral in Subjects Indicated for Small-bowel Enteroscopy or Endoscopic Retrograde Cholangio-Pancreatography (ERCP) in Subjects With Surgically Altered Gastrointestinal Anatomy.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 89 (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 phase B is to assess the performance and safety of diagnostic and therapeutic procedures with the Olympus Motorized Spiral Enteroscope (PowerSpiral) in subjects with surgically altered gastrointestinal anatomy indicated for an Endoscopic Retrograde Cholangio-Pancreatography (ERCP).
Detailed description
The main objective of this registry is to collect data on the safety and performance of the motorized PowerSpiral device during Post-market Clinical Follow-up in subjects with surgically altered gastrointestinal anatomy indicated for an Endoscopic Retrograde Cholangio-Pancreatography (ERCP). It is assumed that this motorized PowerSpiral 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 motorized PowerSpiral device.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Endoscopic Retrograde Cholangio-Pancreatography (ERCP) | Endoscopic Retrograde Cholangio-Pancreatography (ERCP) conducted with motorized PowerSpiral in subjects presenting with surgically altered GI anatomy indicated for ERCP with biliary indication. |
Timeline
- Start date
- 2022-01-17
- Primary completion
- 2023-06-21
- Completion
- 2023-06-21
- First posted
- 2021-11-22
- Last updated
- 2025-03-26
- Results posted
- 2025-03-26
Locations
5 sites across 3 countries: Belgium, Germany, Norway
Source: ClinicalTrials.gov record NCT05129449. Inclusion in this directory is not an endorsement.