Clinical trials: Diaphragms, open to volunteers
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
Stress, Diaphragmatic Breathing
Scalable Intervention for Stress Management
The purpose of this research is to measure the acceptance of a resistance breathing intervention and to assess whether it produces physiological and subjective effects in a laboratory setting.
- Trial name
- NCT07127575
- Testing
- Resistance Breathing Device, Electronic Resistance Breathing Device
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Livotion, LLC
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.
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
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
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.
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
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
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.