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New diaphragm stimulator aims to free patients from ventilators

NCT ID NCT05998018

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

60 people

The number who actually took part.

Started

Sep 2023

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subject is 18 years or older. 2. Subject, or subject's Legally Authorized Representative, understands study requirements, study visits, and is willing and able to provide written informed consent prior to study specific procedures or testing. 3. Subject has been on mechanical ventilation for ≥ 96 hours prior to randomization (intubation or tracheostomy). 4. Subject has failed at least 1 weaning attempt (e.g., site directed spontaneous breathing trial(s) did not result in liberation). 5. At the time of enrollment, the subject is likely to be ventilated for an additional 48 hours, at minimum, in the opinion of the investigator. Exclusion Criteria: 1. Subject has been on invasive mechanical ventilation for \> 45 days. 2. Subject failed to wean due to pre-existing neurological or neuromuscular issues affecting the respiratory muscles (e.g., ALS, phrenic nerve paralysis, inflammatory muscle disease, underlying myopathy, myasthenia gravis, cervical spinal injury). 3. Subject's medical history, known anatomy or investigator's inability to visualize necessary anatomical landmarks that could prevent the safe placement of the pdSTIM leads. 4. Subject is at risk of significant hemorrhage or is currently receiving a full dose of systemic anticoagulation (e.g., IV heparin, high dose of subcutaneous heparin. Subjects on prophylactic anticoagulation or daily aspirin regimen on their own are not excluded unless other exclusion criteria apply). 5. Subject has an implant or external electrical device that may interact or interfere with the pdSTIM System (examples may include cardiac pacemaker, implantable defibrillator, vagal nerve stimulator, spinal cord stimulator, gastric stimulator, diaphragmatic stimulator). 6. Subject has been diagnosed and has been treated for neck cancer within the past 5 years or subject had any prior radiation treatment to the neck. 7. Subject currently has hemodynamic instability due to any cause (e.g., severe sepsis, hemorrhagic shock, or septic shock) with vasopressor support \> 0.1 mg/kg/min of norepinephrine or epinephrine, or equivalent, or is actively being titrated. 8. Subject has a local infection at or around the proposed pdSTIM Lead insertion site. 9. Subject is neutropenic or has signs of significant immunocompromise. (Subjects intubated for respiratory failure due to COVID-19 are not excluded unless other exclusion criteria apply). 10. Subject has severe COPD as indicated by evidence of significant expiratory obstruction on the ventilator flow waveform or, where ventilator flow waveforms are not utilized, has a FEV1 ≤ 30%. 11. Subject has pre-existing severe chronic pulmonary fibrosis. 12. Subject has pleural effusion occupying greater than 1/3 of the pleural space on either side. 13. Subject is currently on or expected to begin neuromuscular blockades. 14. Subject is anticipating withdrawal of life support and/or shift to palliation as the goal of care with less than 6-months life expectancy. 15. Subject is known or suspected to be pregnant or lactating. 16. Subject is currently enrolled in or exited early from a) any investigational drug study or b) an investigational device study that may impact the ability to wean or is directly related to the lungs or diaphragm.

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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

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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