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RECRUITING
NCT05883163
NA

STIMIT Activator 1 IDE Study

Sponsor: Stimit AG

View on ClinicalTrials.gov

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

Interventions

DEVICE

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