Clinical trial · Observational
OSPREY is a Post-market, Global, Multicentre, Observational, Prospective Registry.
OncoSil Pancreatic Cancer Post-marketing Clinical REgistrY (OSPREY)
NCT04493632CI-TRIAL-00076588OSPREYrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Digestive System Disease | — | UNRESOLVED | — |
| Digestive System Neoplasm | Digestive System Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Endocrine Gland Neoplasm | — | UNRESOLVED | — |
| Endocrine System Diseases | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Neoplasms by Site | Neoplasm by Site | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Diseases | — | UNRESOLVED | — |
| Pancreatic Neoplasm | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (5)
- measure
- Safety and tolerability of Device
- timeFrame
- Followed to death or to 24-months post the date of the last enrolled patient implanted with OncoSil™
- description
- The analysis for safety within the real-world setting will be performed. The safety of OncoSil™ is defined by the Adverse Event profile. All safety summaries will be produced for the Intention-To-Treat (ITT) population. Adverse events will be coded using Medical Dictionary for Regulatory Activities (MedDRA). All Adverse Events recorded during the Registry will be listed. Summary tables will be produced for Treatment Emergent Adverse Events (TEAEs). The number and percentage of patients with device-related Adverse Events by system organ class (SOC) and preferred term will be tabulated. Similar summaries will be produced by severity of event (both mild, moderate or severe, CTCAE grade 1-4) and drug and/or device relationship. In addition, summary tables will be produced for serious TEAEs and TEAEs associated with special interest acute/late radiation effects and or withdrawal.
- measure
- Device Implantation Performance
- timeFrame
- 7 years
- description
- Safety of the implantation of OncoSil™ within the target tumour will be measured by means of procedure-related Adverse Events. An assessment of the utility of OncoSil™ Implantation will be made and listed appropriately.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.