OSPREY is a Post-market, Global, Multicentre, Observational, Prospective Registry.
Trial Parameters
Brief Summary
The OSPREY Patient Registry has been developed to collect and assess the performance and safety of the OncoSil™ device when used within the approved indication of unresectable, locally advanced pancreatic cancer, in combination with gemcitabine-based chemotherapy, within a real-world observational registry. The Registry data will provide both complementary and contemporary information to the existing clinical data across various countries and will form part of the post-market clinical follow-up activities for OncoSil™. Therefore, the Registry will be implemented only in countries with regulatory (commercial) approval for the OncoSil™ device.
Eligibility Criteria
Inclusion Criteria: 1. Patients with confirmed unresectable locally advanced pancreatic cancer (LAPC). 2. Patients who undergo OncoSil™ implantation at an eligible treatment facility. 3. Patients who have completed and signed the Patient Informed Consent Form (PICF) for the OSPREY Patient Registry. 4. Pancreatic target tumour recommended size of \<7 cm (longest diameter) and \<110 cc volume. 5. A clinically acceptable ECOG performance status. 6. Patients ≥ 18 years of age at screening. 7. To commence gemcitabine-based chemotherapy, (per Standard-of-Care are according to the approved prescribing schedule) post Registry enrolment. 8. Adequate biochemical tests, coagulation profile, haematological, renal, and hepatic function as determined by the Treating Physician. Exclusion Criteria: 1. Patient Informed Consent Form (PICF) has not been completed and signed for the OSPREY Patient Registry. 2. Patients treated with OncoSil™ within an approved interventional clinical study (company or inve