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

Korábbi kezelés

• Patients treated with OncoSil™ within an approved interventional clinical study (company or investigator-sponsored).
• In the opinion of the Treating Physician, EUS-directed implantation posing undue patient risk. This includes:
  • where previous EUS-FNA was considered technically too difficult to perform;
  • imaging demonstrates multiple collateral vessels surrounding or adjacent to the target tumour within the pancreas;
  • presence (or significant risk) of varices near to the target tumour.
• Evidence of radiographic invasion into stomach or duodenum (if not certain, confirmation must be obtained prior to enrolment).

Más betegség

• Patients who have a known history of hypersensitivity to silicon or phosphorous, or any of the OncoSil™ components

Egyéb

• Patient Informed Consent Form (PICF) has not been completed and signed for the OSPREY Patient Registry.
• Evidence of distant metastases based on review of baseline CT scan.
• More than one primary lesion.
• In the setting of recent, clinically significant pancreatitis, implantation is not recommended.
• Pregnant or intending to commence a pregnancy within 12-months of the intended date of implantation or breastfeeding.

• 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.
• A clinically acceptable ECOG performance status.
• Patients ≥ 18 years of age at screening.
• To commence gemcitabine-based chemotherapy, (per Standard-of-Care are according to the approved prescribing schedule) post Registry enrolment.
• Adequate biochemical tests, coagulation profile, haematological, renal, and hepatic function as determined by the Treating Physician.