STIMIT Activator 1 IDE Study

Recruiting now · Not applicable

Conditions studied: Diaphragm Issues

In brief

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.

Key facts

Study ID

NCT05883163

Run by

Stimit AG

People needed

40

Starts

2024-01-24

Expected to finish

2026-07-01

Last updated by the study team

2025-11-14

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Yale New Haven Hospital — New Haven, Connecticut, United States (enrolling)
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
• University of Virginia Medical Center — Charlottesville, Virginia, United States (enrolling)
• St Michael's Hospital Unity Health Toronto — Toronto, Canada (enrolling)

Full record on ClinicalTrials.gov

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