OncoSil Pancreatic cancer post-marketing clinical REgistrY

PI: Dr. Vincenzo Mazzaferro 

OSPREY is a post-market, multicentre, observational, prospective registry in which data is recorded from patients who undergo OncoSil™ device implantation as part of their clinical care.  

Only patients who undergo treatment with the OncoSil™ device in the commercial (sales) setting will participate in this Registry.  

Every patient in the participating countries who is considered for treatment with OncoSil™ in the commercial setting as part of their clinical care will be approached by the Principal Investigator (or delegate) to consent to participate in the OSPREY Patient Registry.  

Patients who choose not to consent to participate in the OSPREY Patient Registry will not be excluded from being treated with the OncoSil™ device.  

Five hundred patients (implanted with OncoSil™) will be enrolled into the OSPREY Patient Registry. It is anticipated that enrolment will be over a five year period, subject to the rate of commercial adoption of the OncoSil™ device in the market.  

To adequately collect data relating to the performance and safety of the OncoSil™ device, data will be collected from patients over a prescribed 12 month period from enrolment. Patients will then be followed to death or to 24 months post the date of the last enrolled patient implanted with OncoSil™.  

Therefore, the Registry is expected to run for a seven year period.  

Relevant observational data will be collected via medical record review.