Clinical trials: Diaphragm
Mechanical Ventilation
Study of Muscle Effects of BYM338 in Mechanically Ventilated Patients
The purpose of this study is to evaluate the effect of BYM338 on muscle mass and function in Group III failure to wean patients, as compared to placebo controls.
- Trial name
- NCT01868685
- Testing
- BYM338
- Sponsor
- Novartis Pharmaceuticals
Ventilation Therapy; Complications
Diaphragmatic Mobility In Ventilated Assisted Patients
The study was a randomized controlled trial. A total of 24 patients who met the inclusion criteria were included in this study and randomly divided by sealed envelope method into Experimental and Control groups with 12 patients…
- Trial name
- NCT04733261
- Testing
- Diaphragmatic mobility, Chest Physiotherapy
- Where
- Pakistan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Aqua Medical Services (Pvt) Ltd
Spinal Cord Injury, Quadriplegia
Electrical Activation of The Diaphragm for Ventilatory Assist
OBJECTIVES: The objectives of this study are to test the Diaphragm Pacing Stimulation (DPS) System for treating chronic ventilatory insufficiency in persons with respiratory muscle paralysis.
- Trial name
- NCT00010374
- Testing
- NeuRx DPS
- Where
- 5 sites in United States, Canada
- Volunteers
- 54 people
- Sponsor
- Synapse Biomedical
Hernia, Ventral, Hernia, Hiatal
GORE® ENFORM Biomaterial Product Study
A prospective, retrospective, non-randomized, multicenter study with two independent hernia study cohorts (Ventral / Incisional Hernia Repair and Diaphragmatic / Hiatal Hernia Repair).
- Conditions
- Hernia, Ventral, Hernia, Hiatal, Hernia, Diaphragmatic, Incisional Hernia
- Trial name
- ENF 18-06 (NCT04718168)
- Testing
- Gore ENFORM Biomaterial (Preperitoneal), Gore ENFORM Biomaterial (Intraperitoneal)
- Where
- 9 sites in United States
- Volunteers
- 245 people
- Sponsor
- W.L.Gore & Associates
Ventilator-Induced Diaphragm Dysfunction
Study of TransAeris® System for Enhanced Recovery After Surgery in France
This study will be conducted as a randomized trial of the TransAeris system for the prevention and treatment of ventilator-induced diaphragm dysfunction (VIDD) in patients identified prior to surgery to be at greater risk of…
- Trial name
- ERAS (NCT05404477)
- Testing
- TransAeris System
- Where
- France
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Synapse Biomedical
Atrial Fibrillation
First-in-Human Study of the Circle Safe System for Diaphragm Response Monitoring During Pulmonary Vein Ablation
The objective of this first-in-human study is to evaluate the safety and performance of the Circle Safe System in subjects undergoing pulmonary vein ablation for atrial fibrillation.
- Trial name
- SAFE-CMAP (NCT07820631)
- Testing
- Circle Safe System Use During Pulmonary Vein Ablation
- Where
- 4 sites in France, New Zealand
- Volunteers
- 50 people
- Sponsor
- Circle Safe, Inc.
General Laparoscopic Surgeries
Comparison of Laparoscopic Procedures With and Without the Aid of the AutoLap System- a Robotic Camera Holder
The objective of this study is to evaluate the ability to reduce the number of OR personnel required while performing the following procedures: colon resections, cholecystectomies and anti-reflux/hiatal hernia surgery with the…
- Trial name
- NCT02934542
- Testing
- AutoLap system
- Where
- Netherlands
- Volunteers
- 108 people
- Sponsor
- M.S.T. Medical Surgery Technology LTD.
Acute Respiratory Distress Syndrome, Ventilation Therapy; Complications
Phrenic Nerve Stimulation-Induced Lung ReAeration Trial
The Lungpacer PROTECT Diaphragm Pacing Therapy System (DPTS) is a temporary, percutaneously-placed, transvenous, phrenic nerve-stimulating device intended to stimulate the diaphragm to preserve and improve inspiratory muscle…
- Trial name
- PIRAT (NCT04844892)
- Testing
- Lungpacer PROTECT Diaphragm Pacing Therapy
- Where
- France
- Volunteers
- 13 people
- Sponsor
- Lungpacer Medical Inc.
Ventilator-induced Diaphragm Dysfunction, VIDD
Evaluation of heepSync, a Novel Algorithm for Transcutaneous Electrical Stimulation of Respiratory Muscles in Mechanically Ventilated Patients.
Up to 76% of ICU patients on mechanical ventilation develop significant respiratory muscle atrophy within the first 24 hours, contributing to prolonged ventilation, increased morbidity, and higher healthcare costs.
- Conditions
- Ventilator-induced Diaphragm Dysfunction, VIDD, Weaning Failure
- Trial name
- NCT07363902
- Testing
- Heecap
- Where
- 3 sites in Spain
- Volunteers
- 20 people
- Sponsor
- Tesai Care SL
Ventilator Induced Diaphragmatic Dysfunction (VIDD)
PEPNS System Feasibility Study
The purpose of this feasibility study is to evaluate the safety and performance of the PEPNS System in patients that need to be mechanically ventilated for at least 48 hours and up to 7 days in the Intensive Care Unit (ICU).
- Trial name
- NCT03559933
- Testing
- PEPNS System
- Where
- 2 sites in Czechia, Ireland
- Volunteers
- 12 people
- Sponsor
- Stimdia Medical Inc.
Diaphragm Pacing
Clinical Study to Investigate Safety and Performance of TransLoc Electrodes in Patients Undergoing Surgical Procedures
Feasibility study to advance the development of NeuRx Diaphragm Pacing System (DPS) for the intended use of stimulating the diaphragm to provide respiratory assistance in patients at risk of prolonged mechanical ventilation in…
- Trial name
- NCT02410798
- Testing
- TransLoc electrode
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Synapse Biomedical
Heart Failure With Reduced Ejection Fraction
Synchronized Diaphragmatic Stimulation in Symptomatic Heart Failure
RECOVER HF is a clinical study designed to evaluate the safety and efficacy of Synchronized Diaphragmatic Stimulation delivered using the VisONE System in the treatment of patients with heart failure.
- Trial name
- RECOVER-HF (NCT06552637)
- Testing
- Synchronized Diaphragmatic Stimulation
- Where
- 5 sites in United States, Georgia
- Volunteers
- 270 people
- Sponsor
- VisCardia Inc.
Amyotrophic Lateral Sclerosis (ALS)
Motor-Point Stimulation for Conditioning the Diaphragm of Patients With Amyotrophic Lateral Sclerosis (ALS)
The overall goal of this research is to delay the respiratory decline of patients with Amyotrophic Lateral Sclerosis (ALS) thereby increasing their lifespan by conditioning the diaphragm with laparoscopically placed electrodes.
- Trial name
- NCT00420719
- Testing
- Intramuscular diaphragm electrodes
- Where
- 8 sites in United States, France
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Synapse Biomedical
ARDS (Moderate or Severe), AHRF
STimulation to Activate RespIration
Multi-center, randomized, controlled, open-label Phase 2 feasibility trial. Subjects on mechanical ventilation (MV) for acute hypoxemic respiratory failure (AHRF) with lung injury (including subjects who meet criteria for acute…
- Conditions
- ARDS (Moderate or Severe), AHRF, Mechanically Ventilated ICU Patients
- Trial name
- STARI (NCT06832306)
- Testing
- Phrenic Nerve Stimulation
- Where
- 7 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- Lungpacer Medical Inc.
Ventilator Induced Lung Injury
Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing, a First in Human Trial
Study conducted to confirm phrenic nerve stimulation using the Lungpacer LIVE Catheter, confirm capture of the diaphragm and confirm that the diaphragm can be paced in synchrony with mechanical ventilator breaths.
- Trial name
- NCT02670460
- Testing
- LIVE Catheter
- Where
- Paraguay
- Volunteers
- 24 people
- Sponsor
- Lungpacer Medical Inc.
Hiatal Hernia
Miromatrix Biological Mesh for Hiatal Hernia Repair
Miromatrix Medical has developed MIROMESH® - a new, noncrosslinked, acellular mesh derived from the highly vascularized porcine liver.
- Trial name
- NCT02436681
- Testing
- MIROMESH
- Where
- 6 sites in United States
- Volunteers
- 50 people
- Sponsor
- Miromatrix Medical Inc.
Bariatric Surgery Candidate, Hiatal Hernia
Safety and Feasibility of Liver Retraction With the Levita Magnetic Surgical System: Extended Magnetic Grasper Device
The purpose of this study is to evaluate the safety and effectiveness of the Extended Magnetic Grasper Device in patients undergoing bariatric and/or hiatal hernia procedures, as a liver retractor grasping the liver and/or the…
- Trial name
- NCT06432088
- Testing
- Extended Magnetic Grasper Device
- Where
- Chile
- Volunteers
- 30 people
- Sponsor
- Levita Magnetics
Respiratory Failure
Multicenter, Multinational, Follow-Up Clinical Trial of the Performance of RESPINOR DXT to Identify Patients at Increased Risk of Weaning Failure
The study will be a multicenter, multinational, prospective single arm blinded non-interventional follow-up study (from DXT-CS-005) to validate RESPINOR DXT's performance to identify patients at increased risk of weaning failure…
- Trial name
- DE-RISK WF II (NCT05580185)
- Testing
- RESPINOR DXT
- Where
- 8 sites in France, Norway
- Volunteers
- 145 people
- Sponsor
- Respinor AS
Ventilator Induced Diaphragm Dysfunction
A Post-Approval Multicenter Study to Assess the Continued Safety and Effectiveness of the AeroPace® System
A single-arm, prospective, multicenter cohort study to assess the 30-day continued safety and effectiveness of the AeroPace System in patients on mechanical ventilation (MV) at least 96 hours and who have not weaned.
- Trial name
- AERO-PAS (NCT07477054)
- Testing
- Lungpacer Diaphragm Pacing Therapy
- Volunteers
- 120 people
- Sponsor
- Lungpacer Medical Inc.
Diaphragm Issues, Ventilator-Induced Lung Injury
Randomized Study to Investigate the Safety and Performance of Diaphragm Stimulation Coupled With Mechanical Ventilation
This study is a randomized prospective, single-center feasibility study of the use and benefits of NeuRx DPS in patients undergoing tracheostomy for failure to wean.
- Conditions
- Diaphragm Issues, Ventilator-Induced Lung Injury, Tracheostomy
- Trial name
- NCT04457427
- Testing
- NeuRx Diaphragm Pacing System (DPS)
- Where
- Turkey (Türkiye)
- Sponsor
- Synapse Biomedical