OncoSil Pancreatic Cancer Post-marketing Clinical Registry - Italy (OSPRItaly)

OncoSil Medical

Status: Not yet enrolling

Conditions: Locally Advanced Pancreatic Adenocarcinoma

Treatments: Device: OncoSil

Study type: Observational

Funder types: Industry

Identifiers

NCT06399172

OSPRItaly01

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. Patients who have completed and signed the Patient Informed Consent Form (PICF) for the OSPRItaly Patient Registry.

Exclusion criteria

1. Patients participating in an interventional clinical study (company or investigator-sponsored).
2. Use of an investigational agent at the time of enrolment.