OncoSil Pancreatic Cancer Post-marketing Clinical Registry - Italy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: OncoSil.
- Who it may be relevant to
- Registry conditions: Locally Advanced Pancreatic Adenocarcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
OncoSil Pancreatic Cancer Post-marketing Clinical Registry Italy
Overview
The OSPRItaly Patient Registry has been developed to 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.
Interventions
- Device OncoSil
Intra-tumoural implantation
Primary outcome measures
- Safety and tolerability [Time frame: Followed to death or to 24-months after the date of the last enrolled patient.]
- Tumour response [Time frame: 1 year]
- Device implantation Performance [Time frame: 1 year]
- Overall Survival [Time frame: Followed to death or to 24-months after the date of the last enrolled patient]
- Resection Rates [Time frame: Followed to death or 24 months after the date of the last enrolled patient]
Eligibility criteria
Inclusion criteria
- Patients who are eligible for and undergo OncoSil™ implantation at an eligible treatment facility according to the approved OncoSil™ System Instructions for Use (IFU), as part of their clinical care.
- Patients who have completed and signed the Patient Informed Consent Form (PICF) for the OSPRItaly Patient Registry.
Exclusion criteria
- Patients participating in an interventional clinical study (company or investigator-sponsored).
- Use of an investigational agent at the time of enrolment.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06399172 · OSPRItaly01