OSPREY Is A Post-market, Global, Multicentre, Observational, Prospective Registry.

Study Overview

OSPREY is a Post-market, Global, Multicentre, Observational, Prospective Registry.

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.

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.

Pancreatic Neoplasm
Digestive System Neoplasm
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasm
Digestive System Disease
Pancreatic Diseases
Endocrine System Diseases

OSPREY01

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2020-07-21	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-04-29
First Submitted that Met QC Criteria 2020-07-27	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-04-30
First Posted (ACTUAL) 2020-07-30	Results First Posted N/A	Last Verified 2024-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
Safety and tolerability of Device	The analysis for safety within the real-world setting will be performed. The safety of OncoSil™ is defined by the Adverse Event profile. All safety summaries will be produced for the Intention-To-Treat (ITT) population. Adverse events will be coded using Medical Dictionary for Regulatory Activities (MedDRA). All Adverse Events recorded during the Registry will be listed. Summary tables will be produced for Treatment Emergent Adverse Events (TEAEs). The number and percentage of patients with device-related Adverse Events by system organ class (SOC) and preferred term will be tabulated. Similar summaries will be produced by severity of event (both mild, moderate or severe, CTCAE grade 1-4) and drug and/or device relationship. In addition, summary tables will be produced for serious TEAEs and TEAEs associated with special interest acute/late radiation effects and or withdrawal.	Followed to death or to 24-months post the date of the last enrolled patient implanted with OncoSil™
Device Implantation Performance	Safety of the implantation of OncoSil™ within the target tumour will be measured by means of procedure-related Adverse Events. An assessment of the utility of OncoSil™ Implantation will be made and listed appropriately.	7 years
Overall Survival	Overall survival (OS) is defined as the time from enrolment to the date of death from any cause. Patients who are alive or permanently lost to follow-up at the cut-off date for the analysis will be censored at the last date the patient was known to be alive. Overall Survival (OS) will be analysed at the interim analysis and once all 500 OncoSil™ implanted patients have been followed to death or to 24-months post the date of the last enrolled/treated patient.	Followed to death or to 24-months post the date of the last enrolled patient implanted with OncoSil™
tumour response as demonstrated by target tumour response demonstrated by RECIST 1.1	Target (implanted) tumor response (local and distant)	7 years
Resection Rates	Surgical resection rates and outcome	7 years

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Tom Maher

Phone Number: +44 750 4658585

Email: tom.maher@oncosil.com

Study Contact Backup

Name: Nicole G Gaddi, B.Sc Nursing

Phone Number: + 61 (0)428 946 588

Email: nicole.gaddi@oncosil.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

where previous EUS-FNA was considered technically too difficult to perform;
imaging demonstrates multiple collateral vessels surrounding or adjacent to the target tumour within the pancreas;
presence (or significant risk) of varices near to the target tumour. 6. Evidence of radiographic invasion into stomach or duodenum (if not certain, confirmation must be obtained prior to enrolment). 7. In the setting of recent, clinically significant pancreatitis, implantation is not recommended. 8. Pregnant or intending to commence a pregnancy within 12-months of the intended date of implantation or breastfeeding. 9. Patients who have a known history of hypersensitivity to silicon or phosphorous, or any of the OncoSil™ components

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Paul J Ross, MRCP, MBBS, Guy's and St Thomas' NHS Foundation Trust, London, UK

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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