Clinical trials: Diaphragms
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
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.
Respiration, Artificial
Improvement of Weaning From Mechanical Ventilation by Continuous Ultrasound Monitoring of Diaphragm Excursion
Justification: The diaphragm is the main inspiratory muscle. Its dysfunction therefore compromises ventilation, which is necessary for gas exchange. Diaphragmatic dysfunction is frequently observed in resuscitation patients.
- Trial name
- WEAN-US (NCT04008875)
- Where
- 3 sites in France
- Volunteers
- 39 people
- Sponsor
- Respinor AS
Gastroesophageal Reflux Disease, Hiatal Hernia
Transoral Incisionless Fundoplication (TIF) Registry Study for Treatment of Gastroesophageal Reflux Disease (GERD)
The study objective is to evaluate the safety and efficacy of TIF among a broad range of GERD patients treated in routine clinical practice at multiple centers across the United States.
- Trial name
- NCT01118585
- Testing
- TIF Procedure
- Where
- 14 sites in United States
- Volunteers
- 278 people
- Sponsor
- EndoGastric Solutions
Hernia, Paraesophageal Hernia
Randomized, Prospective Controlled Trial of Paraesophageal Hernia Repair With Small Intestinal Submucosa (SIS)
The purpose of this randomized study is to determine whether a type of mesh derived from a layer of pig small intestine (SIS) is of benefit in treating paraesophageal hernias versus standard surgical suture repair.
- Trial name
- NCT00272922
- Testing
- hernia repair
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Cook Group Incorporated
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
Heart Failure With Reduced Ejection Fraction, HFrEF
VisONE Heart Failure Study: Pilot
The VisONE HF pilot is a feasibility pilot for evaluating the benefits and risks of chronically delivering Asymptomatic Diaphragmatic Stimulation in medical refractory heart failure patients using the VisONE™ implantable system…
- Trial name
- NCT03484780
- Testing
- VisONE ADS
- Where
- 3 sites in Georgia, Ukraine
- Volunteers
- 15 people
- Sponsor
- VisCardia Inc.
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
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.
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.
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.
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.
Patients Who Were Scheduled for General and Gynecological Laparoscopic Procedures
Evaluation of the Follow Me Mode of the AutoLap System - A Feasibility Study
The main objectives of this study are to evaluate the performance and ease of use of the Follow me mode of the AutoLap system during general and gynecological laparoscopic procedures.
- Trial name
- NCT02326870
- Testing
- AutoLap
- Where
- 4 sites in Israel, Netherlands
- Volunteers
- 33 people
- Sponsor
- M.S.T. Medical Surgery Technology LTD.
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
- Where
- United States
- 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
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
Diaphragm Issues
STIMIT Activator 1 IDE 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…
- Trial name
- NCT05883163
- Testing
- Stimit Activator 1
- Where
- 4 sites in United States, Canada
- Volunteers
- 40 people
- Sponsor
- Stimit AG
Singing, Breathing Exercise
The Effect of Osteopathy and Complete Vocal Technique on Phonation in Amateur Singers
This study is about breathing function during singing, specifically aimed at improving the functionof the muscles in the respiratory system involved in control over the voice.The goal of the study is to examine if osteopathic…
- Conditions
- Singing, Breathing Exercise, Osteopathy
- Trial name
- NCT07007845
- Testing
- CVT Support intervention, Dooming Diaphragm
- Where
- Denmark
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Complete Vocal Institute
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
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