OSPREY is a Post-market, Global, Multicentre, Observational, Prospective Registry.
Recruiting · NCT04493632 · Observational (researchers observe without assigning treatment) · Lead sponsor: OncoSil Medical Limited
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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
Where it is running
9 locations listed.
- Complejo Hospitalario Universitario Insular Materno-Infantil - Las Palmas de Gran Canaria, Spain
- Hammersmith Hospital - London, United Kingdom
- The London Clinic - London, United Kingdom
- Hospital Universitario Ramón y Cajal - Madrid, Spain
- Hospital Universitario de Fuenlabrada - Madrid, Spain
- Hospital Universitario Doce De Octobre - Madrid, Spain
- Hospital Universitario La Paz - Madrid, Spain
- Clinica Universidad De Navarra - Pamplona, Spain
- Hospital Clinico Universitario De Valladolid - Valladolid, Spain