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

Last updated: April 29, 2024
Sponsor: OncoSil Medical Limited
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neoplasms

Stomach Cancer

Digestive System Neoplasms

Treatment

N/A

Clinical Study ID

NCT04493632
OSPREY01
  • Ages 18-90
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients with confirmed unresectable locally advanced pancreatic cancer (LAPC).
  2. Patients who undergo OncoSil™ implantation at an eligible treatment facility.
  3. Patients who have completed and signed the Patient Informed Consent Form (PICF) forthe OSPREY Patient Registry.
  4. Pancreatic target tumour recommended size of <7 cm (longest diameter) and <110 ccvolume.
  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 theapproved prescribing schedule) post Registry enrolment.
  8. Adequate biochemical tests, coagulation profile, haematological, renal, and hepaticfunction as determined by the Treating Physician.

Exclusion

Exclusion Criteria:

  1. Patient Informed Consent Form (PICF) has not been completed and signed for the OSPREYPatient Registry.
  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 unduepatient risk. This includes:
  • where previous EUS-FNA was considered technically too difficult to perform;
  • imaging demonstrates multiple collateral vessels surrounding or adjacent to thetarget tumour within the pancreas;
  • presence (or significant risk) of varices near to the target tumour.
  1. Evidence of radiographic invasion into stomach or duodenum (if not certain,confirmation must be obtained prior to enrolment).
  2. In the setting of recent, clinically significant pancreatitis, implantation is notrecommended.
  3. Pregnant or intending to commence a pregnancy within 12-months of the intended date ofimplantation or breastfeeding.
  4. Patients who have a known history of hypersensitivity to silicon or phosphorous, orany of the OncoSil™ components

Study Design

Total Participants: 500
Study Start date:
April 12, 2022
Estimated Completion Date:
October 01, 2027

Study 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.

Connect with a study center

  • Complejo Hospitalario Universitario Insular Materno-Infantil

    Las Palmas De Gran Canaria,
    Spain

    Active - Recruiting

  • Hospital Universitario Doce De Octobre

    Madrid,
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid,
    Spain

    Site Not Available

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034
    Spain

    Active - Recruiting

  • Hospital Universitario de Fuenlabrada

    Madrid, 28942
    Spain

    Active - Recruiting

  • Clinica Universidad De Navarra

    Pamplona,
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario De Valladolid

    Valladolid,
    Spain

    Active - Recruiting

  • Hammersmith Hospital

    London,
    United Kingdom

    Site Not Available

  • The London Clinic

    London,
    United Kingdom

    Site Not Available

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