At a glance
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JET Enhanced Thrombectomy Intervention Hong Kong Post Market Study
In Brief
An observational study evaluating JETi Hydrodynamic Thrombectomy System for Peripheral Venous Thrombosis and 2 related conditions. Completed, enrolled 12 participants across 4 sites.
Detailed Summary
The JETi Hong Kong PMS is a single-arm, multicenter study to collect real-world data on the safety, performance, and clinical benefits of the JETi System for the treatment of acute and subacute thrombosis in the peripheral vasculature. This is a post-market study that will register approximately 20 subjects at approximately 5 centers in Hong Kong. Subjects participating in this study will be followed for up to 30 days (in cases of prospective consent) after Day 0. Day 0 is defined as the day when the JETi catheter is introduced into the intended vasculature of the subject.
Study Details
Timeline
Interventions
The JETi Hydrodynamic Thrombectomy System is a hydro-mechanical aspiration system intended for the removal of intravascular thrombus. The system is comprised of the JETi Catheter, JETi Pump Set, and JETi Saline Drive Unit (SDU), accessory cart, suction tubing, and non-sterile canister set. The JETi System is designed to simultaneously deliver a stream of high-pressure saline via a displacement pump to the distal tip of the JETi Catheter, while aspirating thrombotic material macerated by the saline stream.