Diaphragm Issues Clinical Trial
Official title:
STIMIT Activator 1 Pivotal Study
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 48 hours and are predicted to require additional minimum 48 hours of mechanical ventilation or longer (adding up to MV time approximately 96 hours or longer).
The objective of this clinical investigation is to evaluate the safety and efficacy of the STIMIT Activator 1 device in subjects on mechanical ventilation who are on invasive mechanical ventilation (MV) and thus are at risk of diaphragmatic dysfunction/atrophy. 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 48 hours and are predicted to require additional minimum 48 hours of mechanical ventilation or longer (adding up to MV time approximately 96 hours or longer). This pivotal study is expected to include 40 subjects enrolled and device interventions in up to 6 centers focusing on North American sites (main focus USA, > 50% of study enrollment from US site). An interim analysis will be conducted after 30 patients have been treated to reconfirm sample size (adaptive design). This clinical study is anticipated to commence in the US upon approval by FDA and local IRB/EC site approval, and Canada upon approval of competent authorities and Ethics Committees. Enrollment and 10-day follow-up duration for primary endpoint of the study is expected to last 6 months. Subjects will be followed for 10 days or until they are successfully extubated (weaned) from mechanical ventilation, expire, or withdraw consent. ;
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