Status:
RECRUITING
OSPREY is a Post-market, Global, Multicentre, Observational, Prospective Registry.
Lead Sponsor:
OncoSil Medical Limited
Conditions:
Pancreatic Neoplasm
Digestive System Neoplasm
Eligibility:
All Genders
18-90 years
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 pancre...
Detailed Description
OSPREY is a post-market, global, multicentre, observational, prospective registry in which data is recorded from patients who undergo OncoSil™ device implantation. Countries intended for initial comm...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 12 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04493632
Start Date
April 12 2022
End Date
October 1 2027
Last Update
April 30 2024
Active Locations (9)
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1
Complejo Hospitalario Universitario Insular Materno-Infantil
Las Palmas de Gran Canaria, Spain
2
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
3
Hospital Universitario de Fuenlabrada
Madrid, Spain, 28942
4
Hospital Universitario Doce De Octobre
Madrid, Spain