Condition: Pancreatic Neoplasm · Digestive System Neoplasm · Neoplasms by Site · Sponsor: OncoSil Medical Limited
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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.
This description comes directly from the study's public registry record.
Tom Maher · +44 750 4658585 · tom.maher@oncosil.com
Nicole G Gaddi, B.Sc Nursing · + 61 (0)428 946 588 · nicole.gaddi@oncosil.com
There is no obligation to join — the study team can answer your questions about taking part.
Always discuss trial participation with your own doctor first.
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
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Complejo Hospitalario Universitario Insular Materno-Infantil | Las Palmas de Gran Canaria, Spain | Recruiting |
| Hospital Universitario Ramón y Cajal | Madrid, Spain | Recruiting |
| Hospital Universitario de Fuenlabrada | Madrid, Spain | Recruiting |
| Hospital Universitario Doce De Octobre | Madrid, Spain | Not Yet Recruiting |
| Hospital Universitario La Paz | Madrid, Spain | Not Yet Recruiting |
| Clinica Universidad De Navarra | Pamplona, Spain | Recruiting |
| Hospital Clinico Universitario De Valladolid | Valladolid, Spain | Recruiting |
| Hammersmith Hospital | London, United Kingdom | Not Yet Recruiting |
| The London Clinic | London, United Kingdom | Not Yet Recruiting |
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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