Actively Recruiting
STIMIT Activator 1 IDE Study
Led by Stimit AG · Updated on 2025-11-14
40
Participants Needed
4
Research Sites
127 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
STIMIT Activator 1 IDE Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Are 21 years or older
- Have recently been placed on invasive mechanical ventilation and have been on it for no more than 7 days
- Are predicted to require mechanical ventilation for at least 48 hours after randomization
You will not qualify if you...
- Currently treated with continuous infusion of neuromuscular blocking agents beyond enrollment period
- Have medical conditions affecting the phrenic nerve or respiratory muscles
- Have an intracranial pressure (ICP) probe
- Have metallic implants or penetrating metallic devices within 30 cm of the coils or neck anatomy/device interfering with headset placement
- Have non-removable electrical/electronic devices that may interact with the STIMIT Activator (e.g., pacemakers, implantable defibrillators, medication pumps, nerve stimulators, cochlear implants)
- Body mass index (BMI) greater than 40
- Have cardiogenic or septic shock with severe hemodynamic instability not stabilized within enrollment period
- Considered unable to tolerate the initial installation of the STIMIT respiratory sensor by physician
- Anticipating withdrawal of life support or shift to palliative care
- Known pregnancy
- Participating in another clinical trial with experimental interventions affecting primary outcome
- Ultrasonographic assessment of right diaphragm thickness not possible due to local emphysema or large dressings
- Neck conditions preventing coil placement (e.g., open wounds, skin at risk for burns)
- Significant spontaneous breathing efforts (P0.1 less than -2) without risk for diaphragm atrophy or dysfunction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
Actively Recruiting
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
University of Virginia Medical Center
Charlottesville, Virginia, United States, 22908
Actively Recruiting
4
St Michael's Hospital Unity Health Toronto
Toronto, Canada
Actively Recruiting
Research Team
T
Tsiry Rabemahefa
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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