New diaphragm stimulator aims to free patients from ventilators

NCT ID NCT05998018

Terminated Disease control Sponsor: Stimdia Medical Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a device called the pdSTIM System that stimulates the diaphragm in patients who have been on a breathing machine (ventilator) for at least four days and have failed at least one attempt to wean off. The device works by exercising the diaphragm in sync with the ventilator. The trial was terminated early, so we do not have clear evidence on whether it helps patients wean faster or reduces complications.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: pdSTIM System (a device that stimulates the phrenic nerve to exercise the diaphragm)
What this could lead to: If it worked, this device could help patients on ventilators wean off faster, reducing complications and hospital stays.
What could go wrong: The trial was terminated early, so results are limited. It is unclear if the device is safe or effective. Risks include device-related complications or no benefit over standard care.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

MECHANICAL VENTILATION WEANING NEUROMODULATION PHRENIC NERVE STIMULATION VENTILATOR INDUCED DIAPHRAGM DYSFUNCTION

Contacts and locations

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Locations

Abrazo West Campus

Goodyear, Arizona, 85395, United States
Atrium Health Carolinas Medical Center

Charlotte, North Carolina, 28203, United States
Chandler Regional Medical Center

Chandler, Arizona, 85224, United States
Denver Health

Denver, Colorado, 80204, United States
Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States
Grady Memorial Hospital

Atlanta, Georgia, 30303, United States
HonorHealth Research Institute

Scottsdale, Arizona, 85260, United States
Houston Methodist

Houston, Texas, 77030, United States
LSU Health Sciences Center at Shreveport

Shreveport, Louisiana, 71103, United States
Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States
Northwell South Shore University Hospital

Bay Shore, New York, 11706, United States
RML Specialty Hospital

Hinsdale, Illinois, 60521, United States
St. David's Healthcare

Georgetown, Texas, 78626, United States
Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States
Tulane University Medical Center

New Orleans, Louisiana, 70112, United States
University at Buffalo

Buffalo, New York, 14203, United States
University of Illinois Chicago

Chicago, Illinois, 60612, United States
University of Louisville

Louisville, Kentucky, 40202, United States
University of Michigan Health - West

Wyoming, Michigan, 49519, United States
University of South Alabama

Mobile, Alabama, 36617, United States
WakeMed Health

Raleigh, North Carolina, 27610, United States

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