STIMIT Activator 1 Pivotal Study
Stimit AG
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.
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…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DeviceStimit Activator 1
The Stimit Activator 1 System will be used to stimulate the phrenic nerve resulting in diaphragm activation.
Locations (4)
- Yale New Haven HospitalNew Haven, Connecticut
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- University of Virginia Medical CenterCharlottesville, Virginia
- St Michael's Hospital Unity Health TorontoToronto