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.
Patients with confirmed unresectable locally advanced pancreatic cancer (LAPC).
Patients who undergo OncoSil™ implantation at an eligible treatment facility.
Patients who have completed and signed the Patient Informed Consent Form (PICF) for the OSPREY Patient Registry.
Pancreatic target tumour recommended size of <7 cm (longest diameter) and <110 cc volume.
Patient Informed Consent Form (PICF) has not been completed and signed for the OSPREY Patient Registry.
Patients treated with OncoSil™ within an approved interventional clinical study (company or investigator-sponsored).
Evidence of distant metastases based on review of baseline CT scan.
More than one primary lesion.
OncoSil Medical Limited
Lead sponsor