OSPREY Registry to Collect Safety and Performance Data for OncoSil Device in Unresectable Pancreatic Cancer with Gemcitabine Chemotherapy

What this Trial Is About

Researchers are evaluating the OncoSil device in a global, post-market, observational registry called OSPREY. This registry collects data on patients with unresectable, locally advanced pancreatic cancer who receive the device along with gemcitabine-based chemotherapy. The study aims to gather real-world information on the devices performance and safety across multiple countries where it is commercially approved. The study includes patients who undergo OncoSil implantation as part of their standard care in approved treatment centers. Data will be collected over 12 months from each patient after enrollment, with follow-up continuing until death or up to 24 months after the last patient is enrolled. The registry plans to recruit about 500 patients over five years, covering countries including Australia, Belgium, France, Germany, Italy, Singapore, Spain, and the United Kingdom. Participants will have their medical records reviewed to gather relevant clinical data. Researchers will monitor outcomes such as device safety and tolerability, implantation performance, overall survival, tumor response based on RECIST 1.1 criteria, and surgery rates related to tumor removal. The registry is expected to run for seven years, providing long-term information on patient outcomes and device use.

OSPREY is a Post-market, Global, Multicentre, Observational, Prospective Registry.