NCT04493632 OSPREY is a Post-market, Global, Multicentre, Observational, Prospective Registry.
| NCT ID | NCT04493632 |
| Status | Recruiting |
| Phase | — |
| Sponsor | OncoSil Medical Limited |
| Condition | Pancreatic Neoplasm |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2022-04-12 |
| Primary Completion | 2025-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2022-04-12 with a primary completion date of 2025-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
Inclusion Criteria: 1. Patients with confirmed unresectable locally advanced pancreatic cancer (LAPC). 2. Patients who undergo OncoSil™ implantation at an eligible treatment facility. 3. Patients who have completed and signed the Patient Informed Consent Form (PICF) for the OSPREY Patient Registry. 4. Pancreatic target tumour recommended size of \<7 cm (longest diameter) and \<110 cc volume. 5. A clinically acceptable ECOG performance status. 6. Patients ≥ 18 years of age at screening. 7. To commence gemcitabine-based chemotherapy, (per Standard-of-Care are according to the approved prescribing schedule) post Registry enrolment. 8. Adequate biochemical tests, coagulation profile, haematological, renal, and hepatic function as determined by the Treating Physician. Exclusion Criteria: 1. Patient Informed Consent Form (PICF) has not been completed and signed for the OSPREY Patient Registry. 2. Patients treated with OncoSil™ within an approved interventional clinical study (company or investigator-sponsored). 3. Evidence of distant metastases based on review of baseline CT scan. 4. More than one primary lesion. 5. 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. 6. Evidence of radiographic invasion into stomach or duodenum (if not certain, confirmation must be obtained prior to enrolment). 7. In the setting of recent, clinically significant pancreatitis, implantation is not recommended. 8. Pregnant or intending to commence a pregnancy within 12-months of the intended date of implantation or breastfeeding. 9. Patients who have a known history of hypersensitivity to silicon or phosphorous, or any of the OncoSil™ components
Contact & Investigator
Paul J Ross, MRCP, MBBS
PRINCIPAL INVESTIGATOR
Guy's and St Thomas' NHS Foundation Trust, London, UK
Frequently Asked Questions
Who can join the NCT04493632 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Pancreatic Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04493632 currently recruiting?
Yes, NCT04493632 is actively recruiting participants. Contact the research team at tom.maher@oncosil.com for enrollment information.
Where is the NCT04493632 trial being conducted?
This trial is being conducted at Las Palmas de Gran Canaria, Spain, Madrid, Spain, Madrid, Spain, Madrid, Spain and 5 additional locations.
Who is sponsoring the NCT04493632 clinical trial?
NCT04493632 is sponsored by OncoSil Medical Limited. The principal investigator is Paul J Ross, MRCP, MBBS at Guy's and St Thomas' NHS Foundation Trust, London, UK. The trial plans to enroll 500 participants.