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First received: August 11, 2023

Clinical Trial: Randomized Study of the pdSTIM™ System (Phrenic Nerve to Diaphragm STIMulation) in Failure to Wean Mechanically Ventilated Patients

Study Status: Completed

Recruit Status: RECRUITING

Condition: Ventilator Induced Diaphragm Dysfunction

Study Type: INTERVENTIONAL


Official Title: Randomized Study of the pdSTIM™ System (Phrenic Nerve to Diaphragm STIMulation) in Failure to Wean Mechanically Ventilated Patients

Brief Summary: This prospective, multi-center, randomized, controlled clinical trial is being conducted to evaluate the safety and efficacy of the pdSTIM System to facilitate weaning from mechanical ventilation through phrenic nerve stimulation.Potential subjects who are on mechanical ventilation for at least four days and have failed at least one weaning attempt will be considered for the study.Those enrolled will be randomized in a 1:1 manner between the treatment group that is standard of care with the pdSTIM System and a…

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