STIMIT Activator 1 IDE Study

NCT05883163 | Recruiting DMC FDA Device

• 1 other identifier: D-26606
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 4

Brief Summary

The study is a prospective, multi-center, randomized, controlled study using adaptive design to assess the evidence of safety and performance of the STIMIT Activator 1 System in the treatment of patients who have been mechanically ventilated for up to 7 days and are predicted to require additional minimum 48 hours of mechanical ventilation or longer.

Conditions

Diaphragm Issues

Keywords

Non-Invasive Phrenic Nerve Stimulation

Outcome Measures

Primary Outcomes (2)

• Efffectiveness: Preservation of Diaphragm Thickness

  The intra-individual change in diaphragm thickness will be measured daily via ultrasound and compared between intervention and control groups.

  Up to Day 10

• Safety: Rate of device or procedure related serious adverse events (SAEs)

  Events will be collected for intervention group during the course of treatment.

  Up to Day 10

Secondary Outcomes (3)

• Preservation of Diaphragm Thickness

  Up to Day 3

• Time to Rapid Shallow Breathing Index (RSBI) < 105

  Up to Day 10

• Maximum Inspiratory Pressure (MIP) at extubation

  Up to Day 10

Study Arms (2)

Stimulation Group

EXPERIMENTAL

The intervention group will receive non-invasive stimulation of the phrenic nerve for activation of the diaphragm.

Device: Stimit Activator 1

Control Group

NO INTERVENTION

The control group will not received intervention and will be treated with standard of care.

Interventions

Stimit Activator 1 DEVICE

The Stimit Activator 1 System will be used to stimulate the phrenic nerve resulting in diaphragm activation.

Stimulation Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are 21 years or older, and,
• Have recently been placed on invasive MV (enroll and randomized as soon as possible after intubation), and have received no more than 7 days of MV
• Are predicted to remain on mechanical ventilation for an additional 48 hours or longer post randomization

You may not qualify if:

• Patients that are actively treated with continuous infusion of neuromuscular blocking agents beyond the enrollment period.
• Medical condition known to affect the phrenic nerve or respiratory muscles (examples of possible medical conditions that could affect the phrenic nerve provided in Annex 1 below).
• Any patients with ICP probe.
• Patients with metallic device implants or body penetrating metallic devices in the upper body area within 30cm (12inches) from the coils; known anatomy or devices in the neck area (e.g., ECMO cannulas in the neck area, collars or cranial appliances) that would interfere with headset placement or stimulation.
• Any non-removable electrical / electronic device (device internal or external) that may be prone to interaction with, or interference from the STIMIT Activator, such as pacemakers, implantable defibrillators, implanted medication pumps, bio-stimulators, deep brain stimulators, implanted nerve stimulator, deep brain stimulators or cochlear device implants.
• BMI \>40.
• Cardiogenic or septic shock with ongoing severe hemodynamic instability that cannot be stabilized within the enrollment period.
• Physician thinks that the patient will not tolerate initial installation of the STIMIT respiratory sensor.
• Anticipating withdrawal of life support and/or shift to palliation as the goal of care.
• Known to be pregnant.
• Participating in another clinical trial studying an experimental Intervention that could affect the study primary outcome.
• Patients whose ultrasonographic assessment of right-sided diaphragmatic thickness would be too difficult (e.g. local subcutaneous emphysema surrounding the zone of apposition, large dressings in the zone of apposition that cannot be removed).
• Patients with neck condition that would not allow placing the coils on the neck (e.g. open wounds that cannot be covered, skin at risk for burns).
• Patients with significant spontaneous efforts (P0.1 \< - 2) that would not be at risk for diaphragmatic atrophy/ dysfunction.

Sponsors & Collaborators

• Stimit AG: lead

Study Sites (4)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

University of Virginia Medical Center

Charlottesville, Virginia, 22908, United States

RECRUITING

St Michael's Hospital Unity Health Toronto

Toronto, Canada

RECRUITING

Related Publications (1)

• Schreiber AF, Subira C, Sklar M, Santos M, Ko M, Panelli A, Schaller SJ, Theodore D, Rowley DD, Watson D, Bonde P, Baedorf Kassis EN, Talmor DS, Ranieri M, Goligher EC, Slutsky A, Brochard LJ. Multi-center randomized superiority clinical trial in the early phase of mechanically ventilated patients to preserve diaphragm thickness using non-invasive magnetic phrenic nerve stimulation: STIMIT ACTIVATOR 1 pivotal trial. Trials. 2025 Jun 11;26(1):202. doi: 10.1186/s13063-025-08838-2.

  PMID: 40500715 DERIVED

Study Officials

• Laurent Brochard, MD

  St Michael's Hospital Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tsiry Rabemahefa

CONTACT

218-329-7356; tsiry.rabemahefa@stimit.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: An independent, blinded Core Lab will analyze the primary endpoint data.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multi-center, 1:1 randomized, controlled study using adaptive design

Study Record Dates

• First Submitted: May 20, 2023
• First Posted: May 31, 2023
• Study Start: January 24, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: November 14, 2025

Record last verified: 2025-11

Locations

US (3); CA (1)