Actively Recruiting
OncoSil Pancreatic Cancer Post-marketing Clinical REgistrY (OSPREY)
Led by OncoSil Medical Limited · Updated on 2024-04-30
500
Participants Needed
9
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the OncoSil™ device in a global, post-market, observational registry called OSPREY. This registry collects data on patients with unresectable, locally advanced pancreatic cancer who receive the device along with gemcitabine-based chemotherapy. The study aims to gather real-world information on the device's performance and safety across multiple countries where it is commercially approved. The study includes patients who undergo OncoSil™ implantation as part of their standard care in approved treatment centers. Data will be collected over 12 months from each patient after enrollment, with follow-up continuing until death or up to 24 months after the last patient is enrolled. The registry plans to recruit about 500 patients over five years, covering countries including Australia, Belgium, France, Germany, Italy, Singapore, Spain, and the United Kingdom. Participants will have their medical records reviewed to gather relevant clinical data. Researchers will monitor outcomes such as device safety and tolerability, implantation performance, overall survival, tumor response based on RECIST 1.1 criteria, and surgery rates related to tumor removal. The registry is expected to run for seven years, providing long-term information on patient outcomes and device use.
CONDITIONS
Brief Title
OSPREY is a Post-market, Global, Multicentre, Observational, Prospective Registry.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with confirmed unresectable locally advanced pancreatic cancer (LAPC).
- Patients undergoing OncoSil™ implantation at an eligible treatment facility.
- Patients who have signed the Patient Informed Consent Form for the OSPREY Patient Registry.
- Pancreatic target tumor size less than 7 cm in longest diameter and volume less than 110 cc.
- Clinically acceptable ECOG performance status.
- Patients aged 18 years or older at screening.
- Patients planning to start gemcitabine-based chemotherapy according to approved schedules after enrollment.
- Adequate biochemical, coagulation, hematological, renal, and hepatic function as determined by the treating physician.
You will not qualify if you...
- Patient has not completed and signed the Patient Informed Consent Form for the OSPREY Patient Registry.
- Patients treated with OncoSil™ in an approved interventional clinical study.
- Evidence of distant metastases based on baseline CT scan.
- Presence of more than one primary lesion.
- Cases where EUS-directed implantation poses undue risk, including difficult prior EUS-FNA, multiple collateral vessels near tumor, or varices near tumor.
- Radiographic invasion into stomach or duodenum without confirmation.
- Recent clinically significant pancreatitis making implantation unsafe.
- Pregnancy, intending to become pregnant within 12 months, or breastfeeding.
- Known hypersensitivity to silicon, phosphorus, or any OncoSil™ components.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of implantation
Participants undergo implantation of the OncoSil™ device as part of routine commercial care.
1 visit (in-person)
Duration - 12 months from enrollment, then followed until death or up to 24 months after last patient enrollment
Participants are observed for safety, device performance, and overall survival through medical record review.
Data collected through medical record review without additional visits
Trial Site Locations
Total: 9 locations
1
Complejo Hospitalario Universitario Insular Materno-Infantil
Las Palmas de Gran Canaria, Spain
Actively Recruiting
2
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Actively Recruiting
3
Hospital Universitario de Fuenlabrada
Madrid, Spain, 28942
Actively Recruiting
4
Hospital Universitario Doce De Octobre
Madrid, Spain
Not Yet Recruiting
5
Hospital Universitario La Paz
Madrid, Spain
Not Yet Recruiting
6
Clinica Universidad De Navarra
Pamplona, Spain
Actively Recruiting
7
Hospital Clinico Universitario De Valladolid
Valladolid, Spain
Actively Recruiting
8
Hammersmith Hospital
London, United Kingdom
Not Yet Recruiting
9
The London Clinic
London, United Kingdom
Not Yet Recruiting
Research Team
T
Tom Maher
N
Nicole G Gaddi, B.Sc Nursing
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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