STIMIT Activator 1 IDE Study

STIMIT Activator 1 Pivotal Study

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.

Study Overview

• Status: Recruiting
• Conditions: Diaphragm Issues
• Intervention / Treatment: Device: Stimit Activator 1

Detailed Description

The objective of this clinical investigation is to evaluate the safety and effectiness of the STIMIT Activator 1 System in patients who are on invasive mechanical ventilation (MV) and thus are at risk of diaphragmatic dysfunction/atrophy.

The study is expected to enroll 40 participants at up to 8 centers focusing on North American sites (main focus USA, > 50% of study enrollment from US site). An interim analysis will be conducted after 30 participants have been enrolled and compelted their study follow-up to reconfirm sample size (adaptive design). Participants will be followed for up to 10 days or until they are successfully extubated (weaned) from mechanical ventilation, expire prior to extubation, or withdraw consent.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tsiry Rabemahefa; Phone Number: 218-329-7356; Email: tsiry.rabemahefa@stimit.com

Study Locations

• Canada
  • Toronto, Canada
    • Recruiting
    • St Michael's Hospital Unity Health Toronto
    • Principal Investigator: Laurent Brochard, MD
    • Contact: Marlene Santos-Taylor; Email: Marlene.Santos@unityhealth.to
• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Recruiting
      • Yale New Haven Hospital
      • Principal Investigator: Pramod Bonde, MD, FACS
      • Contact: Rodolfo Nelson Molina; Email: Rodolfo.molina@yale.edu
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Beth Israel Deaconess Medical Center
      • Principal Investigator: Elias Baedorf Kassis, MD
      • Contact: Matthew Killam; Email: mkillam@bidmc.harvard.edu
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Recruiting
      • University of Virginia Medical Center
      • Principal Investigator: Danny J. Theodore, MD
      • Contact: Hailey Russo; Email: SXU9RN@uvahealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Are 21 years or older, and,
2. 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
3. Are predicted to remain on mechanical ventilation for an additional 48 hours or longer post randomization

Exclusion Criteria:

1. Patients that are actively treated with continuous infusion of neuromuscular blocking agents beyond the enrollment period.
2. 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).
3. Any patients with ICP probe.
4. 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.
5. 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.
6. BMI >40.
7. Cardiogenic or septic shock with ongoing severe hemodynamic instability that cannot be stabilized within the enrollment period.
8. Physician thinks that the patient will not tolerate initial installation of the STIMIT respiratory sensor.
9. Anticipating withdrawal of life support and/or shift to palliation as the goal of care.
10. Known to be pregnant.
11. Participating in another clinical trial studying an experimental Intervention that could affect the study primary outcome.
12. 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).
13. 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).
14. Patients with significant spontaneous efforts (P0.1 < - 2) that would not be at risk for diaphragmatic atrophy/ dysfunction.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; The control group will not received intervention and will be treated with standard of care.
Experimental: Stimulation Group; The intervention group will receive non-invasive stimulation of the phrenic nerve for activation of the diaphragm.	Device: Stimit Activator 1; The Stimit Activator 1 System will be used to stimulate the phrenic nerve resulting in diaphragm activation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 3
Time to Rapid Shallow Breathing Index (RSBI) < 105	Time from intubation to RSBI<105 breaths/min/L in days will be compared between intervention and control groups.	Up to Day 10
Maximum Inspiratory Pressure (MIP) at extubation	MIP at extubation will be compared between intervention and control groups.	Up to Day 10

Collaborators and Investigators

• Sponsor: Stimit AG
• Investigators: Principal Investigator: Laurent Brochard, MD, St Michael's Hospital Unity Health Toronto

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: May 20, 2023
• First Submitted That Met QC Criteria: May 20, 2023
• First Posted (Actual): May 31, 2023

Study Record Updates

• Last Update Posted (Estimated): November 14, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Non-Invasive Phrenic Nerve Stimulation
• Other Study ID Numbers: D-26606

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes