RecruitingNCT04493632

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

OncoSil Pancreatic Cancer Post-marketing Clinical REgistrY (OSPREY)

Sponsor

OncoSil Medical Limited

Enrollment

500 participants

Start Date

Apr 12, 2022

Study Type

OBSERVATIONAL

Conditions

Neoplasms Neoplasms by Site Pancreatic Neoplasm Digestive System Neoplasm Endocrine System Diseases Endocrine Gland Neoplasm Digestive System Disease Pancreatic Diseases

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

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria8

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.

Exclusion Criteria12

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