NCT05998018

Randomized Study of the pdSTIM™ System in Failure to Wean Mechanically Ventilated Patients

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Stimdia Medical Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 Control group, which is standard of care alone.

Detailed description

The pdSTIM Pivotal Study (ReInvigorate Study) is a prospective, multicenter, randomized, controlled clinical study 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 ≥ 96 hours (4 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 a Treatment group that is standard of care with the pdSTIM System and a Control group that is standard of care only. For the Treatment group, stimulation therapy with pdSTIM will occur daily until the subject is successfully removed from mechanical ventilation or the 30-Day follow-up visit, whichever is sooner. All randomized subjects will be followed to 60 (± 7) days post randomization. Total subject participation will be no longer than 67 days.

Conditions

• Neuromodulation
• Phrenic Nerve Stimulation
• Ventilator Induced Diaphragm Dysfunction
• Mechanical Ventilation Weaning

Interventions

Type	Name	Description
DEVICE	pdSTIM System Therapy	Stimulate the phrenic nerves in synchrony with inspiratory cycles of the ventilator which exercises the diaphragm
OTHER	Conventional Medical Management	Conventional medical management

Timeline

• Start date: 2023-09-29
• Primary completion: 2025-04-14
• Completion: 2025-09-04
• First posted: 2023-08-18
• Last updated: 2026-03-27

Locations

21 sites across 1 country: United States

Regulatory

• FDA-regulated device study