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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.
Official title: STIMIT Activator 1 Pivotal Study
Key Details
Gender
All
Age Range
21 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2024-01-24
Completion Date
2026-07
Last Updated
2025-11-14
Healthy Volunteers
No
Conditions
Interventions
Stimit Activator 1
The Stimit Activator 1 System will be used to stimulate the phrenic nerve resulting in diaphragm activation.
Locations (4)
Yale New Haven Hospital
New Haven, Connecticut, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
St Michael's Hospital Unity Health Toronto
Toronto, Canada