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

Last updated: September 3, 2024
Sponsor: Stimdia Medical Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

pdSTIM System Therapy

Clinical Study ID

NCT05998018
CIP0002
  • Ages > 18
  • All Genders

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.

The primary endpoints focus on time to weaning and serious adverse event rates between the Treatment and Control groups.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject is 18 years or older.

  2. Subject, or subject's Legally Authorized Representative, understands studyrequirements, study visits, and is willing and able to provide written informedconsent 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 spontaneousbreathing 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

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 issuesaffecting the respiratory muscles (e.g., ALS, phrenic nerve paralysis, inflammatorymuscle disease, underlying myopathy, myasthenia gravis, cervical spinal injury).

  3. Subject's medical history, known anatomy or investigator's inability to visualizenecessary anatomical landmarks that could prevent the safe placement of the pdSTIMleads.

  4. Subject is at risk of significant hemorrhage or is currently receiving a full doseof systemic anticoagulation (e.g., IV heparin, high dose of subcutaneous heparin.Subjects on prophylactic anticoagulation or daily aspirin regimen on their own arenot excluded unless other exclusion criteria apply).

  5. Subject has an implant or external electrical device that may interact or interferewith the pdSTIM System (examples may include cardiac pacemaker, implantabledefibrillator, 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 5years 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 ofnorepinephrine 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. (Subjectsintubated for respiratory failure due to COVID-19 are not excluded unless otherexclusion criteria apply).

  10. Subject has severe COPD as indicated by evidence of significant expiratoryobstruction on the ventilator flow waveform or, where ventilator flow waveforms arenot 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 oneither 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 thegoal 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 drugstudy or b) an investigational device study that may impact the ability to wean oris directly related to the lungs or diaphragm.

Study Design

Total Participants: 420
Treatment Group(s): 1
Primary Treatment: pdSTIM System Therapy
Phase:
Study Start date:
September 29, 2023
Estimated Completion Date:
February 28, 2026

Study 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.

Connect with a study center

  • University of South Alabama

    Mobile, Alabama 36617
    United States

    Active - Recruiting

  • Chandler Regional Medical Center

    Chandler, Arizona 85224
    United States

    Active - Recruiting

  • Abrazo West Health

    Goodyear, Arizona 85395
    United States

    Active - Recruiting

  • HonorHealth Research Institute

    Scottsdale, Arizona 85260
    United States

    Active - Recruiting

  • Northeast Georgia Medical Center

    Gainesville, Georgia 30501
    United States

    Active - Recruiting

  • University of Illinois Chicago

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • RML Specialty Hospital

    Hinsdale, Illinois 60521
    United States

    Active - Recruiting

  • University of Louisville

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • Tulane University Medical Center

    New Orleans, Louisiana 70112
    United States

    Active - Recruiting

  • LSU Health Sciences Center at Shreveport

    Shreveport, Louisiana 71103
    United States

    Active - Recruiting

  • University of Michigan Health - West

    Wyoming, Michigan 49519
    United States

    Active - Recruiting

  • Bryan Medical Center

    Lincoln, Nebraska 68506
    United States

    Site Not Available

  • Northwell South Shore University Hospital

    Bay Shore, New York 11706
    United States

    Active - Recruiting

  • University at Buffalo

    Buffalo, New York 14203
    United States

    Active - Recruiting

  • Atrium Health

    Charlotte, North Carolina 28203
    United States

    Active - Recruiting

  • WakeMed Health

    Raleigh, North Carolina 27610
    United States

    Active - Recruiting

  • Forsyth Medical Center

    Winston-Salem, North Carolina 27103
    United States

    Active - Recruiting

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Baptist Clinical Research Institute, Inc.

    Memphis, Tennessee 38120
    United States

    Active - Recruiting

  • St. David's Healthcare

    Georgetown, Texas 78626
    United States

    Active - Recruiting

  • Houston Methodist

    Houston, Texas 77030
    United States

    Active - Recruiting

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