RecruitingNCT04493632

OSPREY is a Post-market, Global, Multicentre, Observational, Prospective Registry.

OncoSil Pancreatic Cancer Post-marketing Clinical REgistrY (OSPREY)

Sponsor

OncoSil Medical Limited

Enrollment

500 participants

Start Date

Apr 12, 2022

Study Type

OBSERVATIONAL

Conditions

Neoplasms Neoplasms by Site Pancreatic Neoplasm Digestive System Neoplasm Endocrine System Diseases Endocrine Gland Neoplasm Digestive System Disease Pancreatic Diseases

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

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This is a patient registry tracking outcomes for people with locally advanced pancreatic cancer who receive a device called OncoSil — a small implant placed directly into the tumor that delivers targeted internal radiation (phosphorus-32 brachytherapy) alongside standard chemotherapy. **You may be eligible if...** - You have confirmed locally advanced pancreatic cancer that cannot be surgically removed - Your tumor measures less than 7cm and you are receiving the OncoSil implant at a participating facility - You are 18 or older with an acceptable performance status - You are starting gemcitabine-based chemotherapy after enrollment **You may NOT be eligible if...** - Your pancreatic cancer has spread to distant organs - Your tumor is too large (over 7cm or over 110cc in volume) - Your blood tests or coagulation levels are inadequate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.