STIMIT Activator 1 IDE Study (NCT05883163)
STIMIT Activator 1 Pivotal Study
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Yale New Haven Hospital — New Haven, Connecticut
Age range: 21 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (4 Sites)
- Yale New Haven Hospital — New Haven, Connecticut
- Beth Israel Deaconess Medical Center — Boston, Massachusetts
- University of Virginia Medical Center — Charlottesville, Virginia
- St Michael's Hospital Unity Health Toronto — Toronto,
📞 Contact the Study Coordinator
Phone: (218) 329-7356
Email: tsiry.rabemahefa@stimit.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.