A Clinical Study With the Medical Device PowerSpiral for Endoscopic Retrograde Cholangio-Pancreatography (ERCP) (SAMISEN-B)

Olympus

Status: Completed

Conditions: Cholangiopancreatography, Endoscopic Retrograde

Treatments: Device: Endoscopic Retrograde Cholangio-Pancreatography (ERCP)

Study type: Observational

Funder types: Industry

Identifiers

NCT05129449

2018-GI (OEKG) - 01 Phase B

Details and patient eligibility

About

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).

Full 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.

Enrollment: 89 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

1. Signed informed consent
2. 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.

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 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
4. Concurrent participation in another competing clinical study
5. Pancreatic indication for ERCP in patient with surgically altered anatomy

Trial design