OSPREY is a Post-market, Global, Multicentre, Observational, Prospective Registry.
NCT ID: NCT04493632
Last Updated: 2024-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2022-04-12
2027-10-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. Patients who undergo OncoSil™ implantation at an eligible treatment facility.
3. Patients who have completed and signed the Patient Informed Consent Form (PICF) for the OSPREY Patient Registry.
4. Pancreatic target tumour recommended size of \<7 cm (longest diameter) and \<110 cc volume.
5. A clinically acceptable ECOG performance status.
6. Patients ≥ 18 years of age at screening.
7. To commence gemcitabine-based chemotherapy, (per Standard-of-Care are according to the approved prescribing schedule) post Registry enrolment.
8. Adequate biochemical tests, coagulation profile, haematological, renal, and hepatic function as determined by the Treating Physician.
Exclusion Criteria
2. Patients treated with OncoSil™ within an approved interventional clinical study (company or investigator-sponsored).
3. Evidence of distant metastases based on review of baseline CT scan.
4. More than one primary lesion.
5. In the opinion of the Treating Physician, EUS-directed implantation posing undue patient risk. This includes:
* 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
18 Years
90 Years
ALL
No
Sponsors
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OncoSil Medical Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Paul J Ross, MRCP, MBBS
Role: PRINCIPAL_INVESTIGATOR
Guy's and St Thomas' NHS Foundation Trust, London, UK
Locations
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Complejo Hospitalario Universitario Insular Materno-Infantil
Las Palmas de Gran Canaria, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital Universitario de Fuenlabrada
Madrid, , Spain
Hospital Universitario Doce De Octobre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Clinica Universidad De Navarra
Pamplona, , Spain
Hospital Clinico Universitario De Valladolid
Valladolid, , Spain
Hammersmith Hospital
London, , United Kingdom
The London Clinic
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Fayna Armas, MD
Role: primary
Ana Garcia, MD
Role: primary
Fernando Pereira, MD
Role: primary
Maria J Tabuenca, MD
Role: primary
Eva Martin, MD
Role: primary
Maria M Rodriguez, MD
Role: primary
Purificacion Rodriguez, MD
Role: primary
Harpreet Wasan, MD
Role: primary
Zarni Win
Role: primary
Other Identifiers
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OSPREY01
Identifier Type: -
Identifier Source: org_study_id
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