Clinical trials: Diaphragm
Ventilator-Induced Lung Injury
Percutaneous Temporary Placement of a Transvenous Phrenic Nerve Stimulator for Diaphragm Pacing Using Jugular Access
Study conducted to confirm phrenic nerve stimulation using the a transvenous Phrenic Nerve Stimulator in the left jugular vein.
- Trial name
- NCT03659552
- Testing
- LIVE Catheter
- Where
- Paraguay
- Volunteers
- 13 people
- Sponsor
- Lungpacer Medical Inc.
Hiatal Hernia
Evaluating Clinical Hiatal Hernia Outcomes Using OviTex®
This study will evaluate hiatal hernia recurrence rate and post-operative complications following the use of OviTex Core Resorbable or OviTex 1S Resorbable.
- Trial name
- ECH2O2 (NCT07070115)
- Testing
- OviTex Reinforced Tissue Matrix
- Where
- 5 sites in United States
- Volunteers
- 173 people
- Sponsor
- Tela Bio Inc
Amyotrophic Lateral Sclerosis (ALS)
Humanitarian Device Exemption Post-Approval Study of NeuRx Diaphragm Pacing System for Amyotrophic Lateral Sclerosis
This post-approval study will follow 60 participants who have ALS, documented chronic hypoventilation, and bilateral phrenic nerve function, and who undergo the surgical implantation procedure to receive the NeuRx Diaphragm…
- Trial name
- NCT01605006
- Testing
- NeuRx Diaphragm Pacing System (DPS)
- Where
- 11 sites in United States
- Volunteers
- 97 people
- Sponsor
- Synapse Biomedical
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
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
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.
Neuromodulation, Phrenic Nerve Stimulation
Randomized Study of the pdSTIM™ System in Failure to Wean Mechanically Ventilated Patients
This prospective, multi-center, randomized, controlled clinical trial is being conducted to evaluate the safety and efficacy of the pdSTIM System to facilitate weaning from mechanical ventilation through phrenic nerve…
- Conditions
- Neuromodulation, Phrenic Nerve Stimulation, Ventilator Induced Diaphragm Dysfunction, Mechanical Ventilation Weaning
- Trial name
- ReInvigorate (NCT05998018)
- Testing
- pdSTIM System Therapy, Conventional Medical Management
- Where
- 16 sites in United States
- Volunteers
- 32 people
- Sponsor
- Stimdia Medical Inc.
Ventilator Induced Diaphragm Dysfunction
Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing (RESCUE1)
An early feasibility study to investigate the safety and feasibility of the Lungpacer Diaphragm Pacing Therapy System (DPTS) as a therapy to recondition and strengthen the diaphragm of patients who have been intubated and…
- Trial name
- RESCUE1 (NCT03107949)
- Testing
- Lungpacer DPTS (Diaphragm Pacing Therapy System)
- Where
- 4 sites in United States
- Volunteers
- 9 people
- Sponsor
- Lungpacer Medical Inc.
Ventilator Induced Diaphragm Dysfunction
Randomized Study of TransAeris® System in Cardiac Surgery Patients at Risk of Prolonged Mechanical Ventilation
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 (NCT04899856)
- Testing
- TransAeris
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Synapse Biomedical
Chronic Obstructive Airway Disease
Clinical Study to Investigate Safety and Performance of NeuRx DPS in Patients Undergoing Bilateral Lung Transplantation
This study is a prospective, single-center feasibility study to acquire more knowledge regarding the NeuRx DPS and develop a routine in the optimal pacing of the diaphragm with this system during the weaning period from…
- Trial name
- NCT02411383
- Testing
- NeuRx Diaphragm Pacing System
- Where
- Belgium
- Volunteers
- 4 people
- Sponsor
- Synapse Biomedical
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
Pilot Study of TransAeris® System in Surgical Patients at Risk of Prolonged Mechanical Ventilation
This study will be conducted as a pilot 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 prolonged…
- Trial name
- TRANSITION (NCT04309123)
- Testing
- TransAeris System
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Synapse Biomedical
Heart Failure With Reduced Ejection Fraction
RECOVER-HF Pilot Study of SDS in Heart Failure
The RECOVER HF pilot is a feasibility study for evaluating a randomized, doubled-blinded study design to determine the benefits and risks of chronically delivering Synchronized Diaphragmatic Stimulation (SDS) in Heart Failure…
- Trial name
- NCT05592392
- Testing
- Synchronized Diaphragmatic Stimulation
- Where
- 2 sites in Georgia, Uzbekistan
- Volunteers
- 35 people
- Sponsor
- VisCardia Inc.
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.
Respiratory Failure
Multicenter, Multinational, 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 study to validate DXT's performance to identify patients at increased risk of weaning failure during the spontaneous breathing trial (SBT).
- Trial name
- DE-RISK WF (NCT04696406)
- Testing
- RESPINOR DXT
- Where
- 9 sites in France, Italy and 1 more
- Volunteers
- 193 people
- Sponsor
- Respinor AS
Gastroesophageal Reflux Disease, Hiatal Hernia
Transoral Incisionless Fundoplication (TIF) Versus Sham for Treatment of Gastroesophageal Reflux Disease (GERD)
The study objective is to evaluate the relative merits, safety and effectiveness of transoral incisionless fundoplication (TIF) in proton pump inhibitor (PPI) dependent GERD patients compared with sham procedure.
- Trial name
- NCT01110811
- Testing
- Transoral Incisionless Fundoplication (TIF)
- Where
- 4 sites in Belgium, France and 1 more
- Volunteers
- 60 people
- Sponsor
- EndoGastric Solutions
Gastroesophageal Reflux Disease, Hiatal Hernia
Randomized EsophyX Versus Sham / Placebo Controlled TIF Trial: The RESPECT Study
The objective of the study is to evaluate the relative merits, safety and effectiveness of the EsophyX transoral device in performing an advanced TIF procedure in patients with "troublesome symptoms" as defined by the Montreal…
- Trial name
- RESPECT (NCT01136980)
- Testing
- TIF Transoral Fundoplication
- Where
- 9 sites in United States
- Volunteers
- 129 people
- Sponsor
- EndoGastric Solutions
Respiration, Artificial
Continuous Measurement of Diaphragm Excursion as a Predictor of Extubation Failure
Background: Patients are put under invasive mechanical ventilation (MV) during respiratory failure because they can no longer breathe in a way that delivers enough oxygen to their body.
- Trial name
- NCT03896048
- Where
- Norway
- Volunteers
- 11 people
- Sponsor
- Respinor AS
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
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.