At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Not specified by the sponsor
- How long the study runs
- Study runs about 66 months (dates as stated)
- About the drug or intervention
- Not specified by the sponsor
- Patient visit burden
- Not specified by the sponsor
In plain English
OSPREY is a worldwide registry study that collects information from patients with locally advanced pancreatic cancer that cannot be removed by surgery. It looks at patients who receive a treatment called OncoSil™, which is implanted into the pancreatic tumour, alongside standard chemotherapy with a drug called gemcitabine. The study is run by OncoSil Medical Limited.
Who can take part
- Adults aged 18 or over
- Have confirmed locally advanced pancreatic cancer that cannot be removed by surgery
- Are having OncoSil™ implanted at an eligible treatment centre
- Have a pancreatic tumour that is generally under 7 cm across and under 110 cc in volume
- Have a good enough general fitness level, as judged by their doctor
- Are due to start gemcitabine-based chemotherapy, as part of standard care, after joining the registry
- Have acceptable blood, kidney, liver and clotting test results, as decided by their doctor
- Have signed the patient consent form for the registry
Who may not be able to
- Have not signed the patient consent form
- Received OncoSil™ as part of another clinical study
- Have evidence that the cancer has spread to other parts of the body, based on a baseline CT scan
- Have more than one primary tumour
- Would face too much risk from the implantation procedure, for example because a previous biopsy was too difficult, or there are many nearby blood vessels or swollen veins around the tumour
- Have scans showing the cancer has grown into the stomach or small bowel (duodenum)
- Have recently had significant inflammation of the pancreas (pancreatitis)
- Are pregnant, planning a pregnancy within 12 months of the implant date, or breastfeeding
- Have a known allergy to silicon, phosphorus, or any part of OncoSil™
What taking part involves
- • Implantation of OncoSil™ into the pancreatic tumour, guided by an endoscopic ultrasound (a scan done via a thin tube passed down the throat)
- • Gemcitabine-based chemotherapy, given as part of standard care, after joining the registry
Time commitment: Not stated — ask the trial team about the number of visits, how long the registry lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 18 Years to 90 Years
- Who
- All
- Number of participants
- 500
- Started
- 2022-04-12
- Last checked
- 2024-04
Plain English Summary
What is this study?
- • Testing a new treatment for pancreatic neoplasm
- • Clinical study - 500 participants
- • 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
Who can take part?
- • Ages 18 Years to 90 Years
- • Diagnosed with pancreatic neoplasm
Where?
- • London - Hammersmith Hospital
- • London - The London Clinic
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
OSPREY is a post-market, global, multicentre, observational, prospective registry in which data is recorded from patients who undergo OncoSil™ device implantation. Countries intended for initial commercial distribution include Australia, Belgium, France, Germany, Italy, Singapore, Spain, \& the United Kingdom. Only patients who are intended to undergo treatment with the OncoSil™ device in the commercial (sales) setting will participate in this Registry. Every patient who is prescribed OncoSil™ in the commercial setting will be approached by the Treating Physician to consent to participate in the OSPREY Patient Registry. Patients who choose not to consent to participate in the OSPREY Patient Registry will not be excluded from being treated with the OncoSil™ device. Five hundred patients (implanted with OncoSil™) will be recruited into the OSPREY Patient Registry. It is anticipated recruitment will be over a five-year period, subject to the rate of commercial adoption of the OncoSil™ device in the market. To adequately collect data relating to the performance and safety of the OncoSil™ device, data will be collected from patients over a prescribed 12-month period from enrolment, the cohort is then followed to death or to 24-months post the date of the last enrolled patient implanted with OncoSil™. Therefore, the Registry is expected to run for a seven-year period. Relevant observational data will be collected via medical record review.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 90 Years
- Who can join: All genders
What the study is looking for
- ✓Patients with confirmed unresectable that has grown locally pancreatic cancer (LAPC).
- ✓Patients who undergo OncoSil™ implantation at an eligible treatment facility.
- ✓Patients who have completed and signed the Patient agreement to take part Form (PICF) for the OSPREY Patient Registry.
- ✓Pancreatic target tumour recommended size of \<7 cm (longest diameter) and \<110 cc volume.
- ✓A clinically acceptable ECOG performance status.
Who cannot take part
- ✗Patient agreement to take part Form (PICF) has not been completed and signed for the OSPREY Patient Registry.
- ✗Patients treated with OncoSil™ within an approved interventional clinical study (company or investigator-sponsored).
- ✗Evidence of distant metastases based on review of baseline CT scan.
- ✗More than one primary lesion.
- ✗In the opinion of the Treating Physician, EUS-directed implantation posing undue patient risk. This includes:
See the full criteria
Where Is This Study? (2 UK sites)
Hammersmith Hospital
London, United Kingdom
The London Clinic
London, United Kingdom
How to Get in Touch
Tom Maher
Sponsor contactCONTACT
Nicole G Gaddi, B.Sc Nursing
Sponsor contactCONTACT