OSPREY
Research type
Research Study
Full title
OncoSil pancreatic cancer post‐marketing clinical registry
IRAS ID
283268
Contact name
Paul Ross
Contact email
Sponsor organisation
OncoSil Medical Limited
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 0 months, 1 days
Research summary
OSPREY is a global multi-centre patient registry that will recruit 500 patients across 10-20 sites over a 5 year period. The purpose of the patient registry is to monitor the safety and performance of an active implantable medical device called OncoSil™, when implanted into patients with pancreatic cancer, who will be receiving gemcitabine-based chemotherapy. The OncoSil™ device is approved for use in the treatment for unresectable (unable to surgically remove), locally advanced pancreatic cancer in combination with gemcitabine-based chemotherapy. Only patients undergoing treatment with the OncoSil™ device at authorised participating treatment facilities will be asked to participate in this patient registry. Participation in this patient registry does not require any additional tests or procedures or visits that would be in addition to any regular standard-of-care treatment with OncoSil™ in combination with chemotherapy. If a patient is eligible to receive treatment with the OncoSil™ device and chemotherapy and agrees to participate in the patient registry, information relating to safety and performance of the device will be collected approximately every 8 weeks for up to 12 months post enrolment. After which, survival status will be collected every 3 months until patient death or 24 months post the date of the last patient enrolled into the registry. The data collected from the patient registry will provide current real time information on the OncoSil™ device to supplement the existing clinical data and fulfil the post-market follow-up activities.
REC name
London - Stanmore Research Ethics Committee
REC reference
20/LO/1276
Date of REC Opinion
2 Feb 2021
REC opinion
Further Information Favourable Opinion