MedTrace Logo

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

NCT05998018 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-03-27

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Stimdia Medical Inc.

    lead INDUSTRY

Principal Investigators

  • Steven Conrad, MD,PhD · LSU Health Sciences Shreveport

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-29
Primary Completion
2025-04-14
Completion
2025-09-04
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05998018 on ClinicalTrials.gov