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