Clinical Trials Logo

Clinical Trial 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 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).


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05883163
Study type Interventional
Source Stimit AG
Contact Mary B Tate
Phone 7347092080
Email marybeth.kepler@globalmedicaldeviceconsultants.com
Status Recruiting
Phase N/A
Start date November 7, 2023
Completion date March 31, 2025

See also
  Status Clinical Trial Phase
Completed NCT05748522 - Functional Movement Analysis (FMS) of Diaphragmatic Breathing-Immediate Effect on Shoulder Mobility N/A
Active, not recruiting NCT06257589 - A Chart Review to Evaluate the Safety and Efficacy of Phrenic Nerve Reconstruction for the Treatment of Diaphragmatic Paralysis
Recruiting NCT05211661 - Diaphragm Atrophy and Dysfunction in Mechanical Ventilation
Recruiting NCT06418334 - Ultrasonographic Measurement of Diaphragmatic Thickness in Adolescents With Thoracal Hyperkyphosis
Recruiting NCT06417944 - The Effect of Three-dimensional Exercise (Schroth Exercise) on Diaphragm Thickness in Adolescent Idiopathic Scoliosis Patients
Completed NCT05670327 - Diaphragmatic Ultrasound and Weaning After Lung Transplant.
Recruiting NCT04962568 - Ultrasonographic Evaluation of the Diaphragm During NHF Versus NIV Use in Respiratory Failure N/A
Recruiting NCT05951114 - Post-neurosurgical Respiratory Muscle Dysfunction
Completed NCT05833243 - Effectiveness of Modified Diaphragmatic Training for Gastroesophageal Reflux Disease Post Covid-19 N/A
Completed NCT04700943 - Ultrasound Assessment of Diaphragmatic Dysfunction in Regional Anesthesia
Withdrawn NCT04457427 - Randomized Study to Investigate the Safety and Performance of Diaphragm Stimulation Coupled With Mechanical Ventilation N/A
Recruiting NCT06396949 - The Relationship Between Diaphragm Muscle Thickness and Fibromyalgia
Completed NCT05128552 - Effect of Lung Volume Recruitment Technique After Extubation N/A
Not yet recruiting NCT05787626 - Efficacy of the Transverse Planes Technique in the Diaphragmatic Region in Young Subjects. N/A