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Clinical trial

A Two Phases Clinical Investigation Consisting of a Pre-Market, Pilot, Interventional, Not Randomized, Monocentric Investigation to Evaluate the Safety of PVC Arterial Cannula and PVC Venous Cannula (Class III Medical Devices) Intended to be Used During Cardiopulmonary Bypass (CPB) Procedure Followed by a Pre-Market, Pivotal, Interventional, Randomized, Non- Inferiority, Monocentric Investigation to Confirm the Safety and Evaluate the Performance of the Same Cannulas

NCT07354841 is registered in ClinicalTrials.gov with Eurosets S.r.l. as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
A Two Phases Clinical Investigation Consisting of a Pre-Market, Pilot, Interventional, Not Randomized, Monocentric Investigation to Evaluate the Safety of PVC Arterial Cannula and PVC Venous Cannula (Class III Medical Devices) Intended to be Used During Cardiopulmonary Bypass (CPB) Procedure Followed by a Pre-Market, Pivotal, Interventional, Randomized, Non- Inferiority, Monocentric Investigation to Confirm the Safety and Evaluate the Performance of the Same Cannulas
Lead sponsor
Eurosets S.r.l.
Phase
Not applicable
Overall status
Recruiting
Start date
October 21, 2025
Completion date
September 30, 2026
Enrollment
80 (estimated)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

aortic valve surgery, arterial cannulation, cannulation, cardiac surgery, cardiopulmonary bypass, coronary surgery, coronary surgery with cardiopulmonary bypass, heart surgery, venous cannulation