NCT05883163

STIMIT Activator 1 IDE Study

STIMIT Activator 1 Pivotal Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Stimit AG · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 days or until they are successfully extubated (weaned) from mechanical ventilation, expire prior to extubation, or withdraw consent.

Conditions

• Diaphragm Issues

Interventions

Type	Name	Description
DEVICE	Stimit Activator 1	The Stimit Activator 1 System will be used to stimulate the phrenic nerve resulting in diaphragm activation.

Timeline

• Start date: 2024-01-24
• Primary completion: 2026-04-01
• Completion: 2026-07-01
• First posted: 2023-05-31
• Last updated: 2025-11-14

Locations

4 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study