Actively Recruiting
OSPREY is a Post-market, Global, Multicentre, Observational, Prospective Registry.
Led by OncoSil Medical Limited · Updated on 2024-04-30
500
Participants Needed
9
Research Sites
285 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 who undergo OncoSil1 implantation at an eligible treatment facility.
- Patients who have completed and signed the Patient Informed Consent 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.
- Patients 6 18 years of age at screening.
- To commence gemcitabine-based chemotherapy, (per Standard-of-Care are according to the approved prescribing schedule) post Registry enrolment.
- Adequate biochemical tests, coagulation profile, haematological, renal, and hepatic function as determined by the Treating Physician.
You will not qualify if you...
- Patient Informed Consent Form (PICF) has not been completed and signed for the OSPREY Patient Registry.
- Patients treated with OncoSil1 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 including: previous EUS-FNA technically too difficult; multiple collateral vessels near the tumour; presence or risk of varices near the tumour.
- Evidence of radiographic invasion into stomach or duodenum (if uncertain, confirmation required before enrolment).
- Recent, clinically significant pancreatitis contraindicating implantation.
- Pregnant or intending to commence pregnancy within 12 months of implantation or breastfeeding.
- Known history of hypersensitivity to silicon, phosphorous, or any OncoSil1 components.
AI-Screening
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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
CONTACT
N
Nicole G Gaddi, B.Sc Nursing
CONTACT
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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