N/A
Completed N=89
A Clinical Study With the Medical Device PowerSpiral for Endoscopic Retrograde Cholangio-Pancreatography (ERCP)
Cholangiopancreatography, Endoscopic Retrograde
Source: ClinicalTrials.gov NCT05129449 ↗
Enrolled (actual)
89
Serious AEs
6.8%
Results posted
Mar 2025
Primary outcomePrimary: Total Success Rate. Defined as the Combined Percentage of Enteroscopy Success Rate, Biliary Cannulation Success Rate and Procedural (Therapeutic) Success Rate. — 45 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Success Rate. Defined as the Combined Percentage of Enteroscopy Success Rate, Biliary Cannulation Success Rate and Procedural (Therapeutic) Success Rate. |
45 | — |
| PRIMARY Total Procedure Time |
71.1 | — |
| PRIMARY Enteroscopy Time |
29.4 | — |
| PRIMARY (Serious) Adverse Events and Device Deficiencies. |
6; 1; 81 | — |
Eligibility Criteria
Inclusion criteria
- Signed informed consent
- Patients with surgically altered upper Gastrointestinal anatomy (Roux-en-Y and Billroth II types) with a biliary indication for ERCP where access with conventional ERCP devices is of no avail and after careful risk assessment.
Exclusion criteria In addition to be eligible for study enrollment a subject must not meet any of the exclusion criteria listed below.
- 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 or ERCP (e.g. severe coagulopathy or known coagulation disorder; bowel obstruction / stenosis, stents or other instruments implanted in the intestinal tract, suspected GI perforation, esophageal or gastric varices, eosinophilic esophagitis) as judged by the investigator after careful individual risk assessment
- Concurrent participation in another competing clinical study
- Pancreatic indication for ERCP in patient with surgically altered anatomy
Data sourced from ClinicalTrials.gov (NCT05129449). 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.