Clinical trials: Diaphragms
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
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
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
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
Ventilator Induced Diaphragm Dysfunction
Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing
A randomized clinical trial to investigate the use of the temporary Diaphragm Pacing Therapy System (DPTS) to rehabilitate the diaphragm in mechanically ventilated patients who have failed at least two weaning attempts.
- Trial name
- RESCUE2 (NCT03096639)
- Testing
- Diaphragmatic Pacing Therapy DPTS
- Where
- 21 sites in France, Germany
- Volunteers
- 110 people
- Sponsor
- Lungpacer Medical Inc.
Contraception
Open Label Study of the Safety and Contraceptive Efficacy of BufferGel® With Diaphragm
The purpose of this study is to study the safety and contraceptive effectiveness of BufferGel used with a contraceptive diaphragm.
- Trial name
- NCT00397670
- Testing
- Drug: BufferGel® with diaphragm
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- ReProtect 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.
General Laparoscopic Surgery Candidate, Bariatric Laparoscopic Surgery Candidate
Usability and Performance Evaluation of the AutoLap System - a Feasibility Study
The main objectives of this study are to evaluate the ease of use and performance of the AutoLap system compared to human camera holder during general and bariatric laparoscopic surgeries.
- Trial name
- NCT02346552
- Testing
- AutoLap
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- M.S.T. Medical Surgery Technology LTD.
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.
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
Amyotrophic Lateral Sclerosis
NeuRx Diaphram Pacing System (DPS) Use in Amyotrophic Lateral Sclerosis (ALS)
The purpose of this research study is to collect more information about the use, safety, and effectiveness of the NeuRx DPS® in ALS patients.
- Trial name
- PARADIGM (NCT03034317)
- Testing
- NeuRx DPS
- 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 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.
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.
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
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.
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
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.
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
Healthy Subjects, Elective Surgical Procedure
"Electromagnetical Stimulation of Phrenic Nerve to Generate Contraction of the Diaphragm"
The scientific study is intended to show that external non-invasive electromagnetic stimulation can be used to safely and effectively stimulate the phrenic nerve in awake healthy subjects as well as in ventilated, anesthetized…
- Trial name
- NCT04884698
- Testing
- Stimit Activator
- Where
- Switzerland
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Stimit AG