OncoSil Pancreatic Cancer Post-marketing Clinical Registry - Italy

NCT ID: NCT06399172

Last Updated: 2024-05-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-30
• Study Completion Date: 2029-10-30

Brief Summary

The OSPRItaly Patient Registry has been developed to 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.

Conditions

Locally Advanced Pancreatic Adenocarcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

OncoSil

Intra-tumoural implantation

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patients who are eligible for and undergo OncoSil™ implantation at an eligible treatment facility according to the approved OncoSil™ System Instructions for Use (IFU), as part of their clinical care.

2. Patients who have completed and signed the Patient Informed Consent Form (PICF) for the OSPRItaly Patient Registry.

Exclusion Criteria

1. Patients participating in an interventional clinical study (company or investigator-sponsored).

2. Use of an investigational agent at the time of enrolment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OncoSil Medical Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

OSPRItaly01

Identifier Type: -

Identifier Source: org_study_id