N/A
Completed N=302
A Clinical Study With the Medical Device PowerSpiral for Deep Enteroscopy
Small Bowel Disease
Source: ClinicalTrials.gov NCT03955081 ↗
Enrolled (actual)
302
Serious AEs
2.4%
Results posted
Jan 2024
Primary outcomePrimary: Collect Serious Adverse Events and Device Deficiencies to Demonstrate Safety of the Motorized Spiral Endoscope (PowerSpiral) in Daily Medical Practice. — 6; 1 participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Collect Serious Adverse Events and Device Deficiencies to Demonstrate Safety of the Motorized Spiral Endoscope (PowerSpiral) in Daily Medical Practice. |
6; 1 | — |
| SECONDARY Number of Participants With Therapeutic Yield |
172 | — |
| SECONDARY Number of Participants With Procedures That Confirmed Previous Diagnosis |
251 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03955081). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.