Ignite Creation Date:
2025-12-24 @ 9:27 PM
Ignite Modification Date:
2025-12-25 @ 7:12 PM
Study NCT ID:
NCT04493632
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2020-07-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
OSPREY is a Post-market, Global, Multicentre, Observational, Prospective Registry.
Sponsor:
OncoSil Medical Limited
Organization:
Study Overview
Official Title:
OncoSil Pancreatic Cancer Post-marketing Clinical REgistrY (OSPREY)
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OSPREY
Brief 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.
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: