Clinical trial · Observational

OncoSil Pancreatic Cancer Post-marketing Clinical Registry - Italy

OncoSil Pancreatic Cancer Post-marketing Clinical Registry Italy

NCT06399172CI-TRIAL-00076729OSPRItalynot yet recruitingClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Locally Advanced Pancreatic Adenocarcinoma	Pancreatic Adenocarcinoma	CURATED_BROADER	0.78

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
OncoSil	Device	—	UNRESOLVED

Design

Arms and outcomes

Arms (0)

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Primary outcomes (5)

measure
Safety and tolerability
timeFrame
Followed to death or to 24-months after the date of the last enrolled patient.
description
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 Device Effects will be coded using Medical Dictionary for Regulatory Activities (MedDRA). All Adverse Device Effects recorded during the Registry will be listed. Summary tables will be produced for Treatment Emergent Adverse Device Effects (TEADEs). 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 device relationship. In addition, summary tables will be produced for serious TEADEs and TEADEs associated with special interest acute/late radiation effects and or withdrawal.
measure
Tumour response
timeFrame
1 year
description
Target (implanted) tumour response (local and distant)
measure

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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.

References

Publications (0)

Data not yet available

No reference posted for this study.