STIMIT Activator 1 IDE Study

Recruiting N/A Interventional Study
Diaphragm Issues
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
21 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
Stimit AG · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
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 ran…
Contacts

Tsiry Rabemahefa

218-329-7356

tsiry.rabemahefa@stimit.com

CONTACT