RecruitingNot ApplicableNCT05883163

STIMIT Activator 1 IDE Study

STIMIT Activator 1 Pivotal Study


Sponsor

Stimit AG

Enrollment

40 participants

Start Date

Jan 24, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Stimit Activator 1 for people with diaphragm issues. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 21 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 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

View Full Details on ClinicalTrials.gov

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NCT05883163


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