Clinical trials: Medical Device Performance
Airway Morbidity
Bronchoscopic Endotracheal Intubation Through a SAD - Physician Performance
Prospective observational study with the primary objective is to assess technical competence in anaesthesiology specialists who perform bronchoscopic endotracheal intubation through a supraglottic airway device (SAD), by using a…
- Trial name
- NCT04743440
- Testing
- Bronchoscopic endotracheal intubation through a supraglottic airway device
- Where
- Denmark
- Volunteers
- 100 people
- Sponsor
- Nordsjaellands Hospital
Thromboembolic Events
Clinical Performance Evaluation of Pefakit® PiCT® UC In Vitro Diagnostic Medical Device
To demonstrate the substantial equivalence (SE) of Pefakit® PiCT® UC (test device, T) to aPTT-SP (Hemosil) (predicate device, P) in determining heparin levels in subjects undergoing heparin therapy in support of a United States…
- Trial name
- NCT02052544
- Where
- 3 sites in United States, Germany and 1 more
- Volunteers
- 123 people
- Sponsor
- dsm-firmenich Switzerland AG
NEC
Sensing Oxygen Saturations Using Abdominal NIRS With an Investigational Realtime Device (Songbird)
Preterm infants are highly vulnerable and may suffer from multiple life-threatening conditions that manifest low tissue oxygenation (StO2).
- Trial name
- (Songbird) (NCT05278247)
- Testing
- NIRS
- Volunteers
- 50 people
- Sponsor
- Carag AG
Distal Radius Fracture, Distal Ulna Fracture
PMCF Study on the Safety, Performance and Clinical Benefits of the DVR Plating System
The study is a single-center, retrospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to confirm safety, performance and clinical benefits of the DVR Plates.
- Conditions
- Distal Radius Fracture, Distal Ulna Fracture, Osteotomy
- Trial name
- NCT04653051
- Where
- United Kingdom
- Volunteers
- 111 people
- Sponsor
- Zimmer Biomet
Implantable Cardioverter Defibrillators, CRT-D Cardiac Resynchronization Therapy Defibrillator
LONGEVITY Study. Evaluation of the Device and Battery Longevity of Boston Scientific Market-released ICD and CRT-D Devices
The study is to determine the rate and cause of device replacements at 5 years post-implantation. It will assess the battery and device longevity of the Implantable Cardioverter Defibrillators (ICD) and CRT-D Cardiac…
- Trial name
- NCT02091011
- Where
- 80 sites in United States, Canada and 6 more
- Volunteers
- 1,600 people
- Sponsor
- Boston Scientific Corporation
Gait Impairment, Cerebral Palsy (CP)
Clinical Investigation to Validate the Safety and Performance of the ABLE Kids Device in Pediatric Patients With Neurological Gait Disorders in a Clinical Setting
The primary objective of the study is to validate the safety and clinical performance of the ABLE Kids device in pediatric patients with neurological gait disorders or muscular weakness during a 10-session gait training program…
- Conditions
- Gait Impairment, Cerebral Palsy (CP), Neuromuscular Diseases (NMD), Spinal Cord Injuries (SCI)
- Trial name
- NCT07745712
- Testing
- ABLE Kids
- Where
- Spain
- Volunteers
- 15 people
- Sponsor
- ABLE Human Motion S.L.
RDS of Prematurity, Preterm Birth
Pivotal Study to Assess Safety and Performance of Neola®, a Novel Lung Monitoring Device for Neonates
Pivotal study to assess safety and performance of Neola®, a novel lung monitoring device for neonates
- Conditions
- RDS of Prematurity, Preterm Birth, Lung Diseases
- Trial name
- NCT07060911
- Testing
- Lung monitoring with the Neola device
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Neola Medical Inc
Sudden Cardiac Arrest, Emergency Care
Tempus Pro Monitor Registry
A multicenter, prospective and retrospective, observational, post market study.
- Trial name
- NCT05587764
- Testing
- Standard of Care
- Where
- United States
- Volunteers
- 103 people
- Sponsor
- Heartstream US LLC
Transfusion Reaction
Clinical Performance Study of Safety Test ABO Device
The study aims to confirm the performance equivalence of the in vitro diagnostic device Safety Test ABO with the ABTest Card device.
- Trial name
- NCT06543771
- Testing
- Safety Test ABO and ABTest Card®
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Diagast
Malaria
Performance Evaluation of Malaria Plus Rapid Diagnostic Tests (RDTs) for the Detection of Plasmodium Infections in Patients With Symptoms Suggestive of Malaria
This trial is part of a portfolio of studies designed to assess the clinical and operational performance of Abbott's NxTekTM Malaria Pf Plus and NxTekTM Malaria Pf/Pv Plus Rapid Test Devices.
- Trial name
- NCT05286359
- Testing
- NxTekTM Malaria Pf Plus Rapid Diagnostic Test Device
- Where
- Ethiopia
- Volunteers
- 1,023 people
- Sponsor
- Abbott Rapid Dx
Hepatolenticular Degeneration; Wilson
Performance and Safety of MEX-CD1 Low-volume Continuous Veno-venous Haemodialysis Medical Device for Copper-extraction in Patients With Wilson's Disease
The goal of this clinical trial is to test the MEX-CD1 hemodialysis medical device in patients suffering from Wilson's Disease. The main questions it aims to answer are: Does the device work as expected by removing the excess of…
- Trial name
- MEXWILS (NCT05917327)
- Testing
- Low-volume continuous veno-venous haemodialysis
- Where
- 4 sites in France, Spain
- Volunteers
- 1 people
- Sponsor
- Mexbrain
General Anesthesia, Supraglottic Airway Device
The Accuracy of the Performance and Placement Test for Predicting Supraglottic Airway Device (SAD) Position in the Hypopharynx as Confirmed With Video Laryngoscopy
The supraglottic airway device (SAD) is currently widely used in patients undergoing general anaesthesia as a method of securing the airway.
- Conditions
- General Anesthesia, Supraglottic Airway Device, Laryngeal Mask Airway
- Trial name
- NCT03643029
- Testing
- Video-laryngoscopy following SAD insertion
- Volunteers
- 50 people
- Sponsor
- University of Malaya
Infection, Bacterial
Clinical Performance Evaluation of AI-Enabled Automated Gram Staining Device
The investigators have developed an analysis AI for Gram staining. In this study, the investigators will compare the testing accuracy of automated Gram staining equipment with AI with the testing accuracy of laboratory…
- Trial name
- NCT06143657
- Testing
- Automated Gram Staining Machine analysis
- Volunteers
- 1,600 people
- Sponsor
- GramEye
Wounds
Simplified Negative Pressure Wound Therapy
The objective of this study is to implement a simplified Negative Pressure Wound Therapy (sNPWT) device in a low resource setting.
- Trial name
- NCT01339429
- Testing
- simplified negative pressure wound therapy device (Wound Pump device)
- Where
- 2 sites in Rwanda
- Volunteers
- 41 people
- Sponsor
- Brigham and Women's Hospital
Colo-rectal Cancer
Therascreen® KRAS RGQ PCR Kit
An interventional, prospective IVD device study for the testing of DNA extracted from tumor tissue biopsy samples from patients with Colorectal Cancer (CRC) who have previously tested positive for the KRAS G12C mutation for…
- Trial name
- NCT05347745
- Testing
- therascreen® KRAS RGQ PCR Kit
- Where
- United Kingdom
- Volunteers
- 219 people
- Sponsor
- QIAGEN Gaithersburg, Inc
RDS of Prematurity, Preterm Birth
Study to Assess Safety and Performance of Neola®, a Novel Lung Monitoring Device for Neonates
Clinical pilot study to assess safety and performance of Neola®, a novel lung monitoring device for neonates
- Conditions
- RDS of Prematurity, Preterm Birth, Lung Diseases
- Trial name
- NCT06917326
- Testing
- Monitoring
- Where
- Sweden
- Volunteers
- 10 people
- Sponsor
- Neola Medical AB
Scoliosis
Study of the Surgical Treatment of Early Onset Scoliosis Using a Non-invasive Growing Rod
It is current practice for children who have surgery for early onset scoliosis (EOS) to be treated with insertion of extendable implants known as growth rod systems.
- Trial name
- NCT01362881
- Where
- 2 sites in United Kingdom
- Volunteers
- 14 people
- Sponsor
- Ellipse Technologies, Inc.
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Evaluation of the GlucoTrack, Non-Invasive Glucose Monitoring Device
The purpose of this study is to demonstrate the performance of the GlucoTrack device (non invasive device) in measuring blood glucose levels
- Conditions
- Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus, Gestational Diabetes
- Trial name
- NCT00433758
- Testing
- GlucoTrack
- Where
- Israel
- Volunteers
- 142 people
- Sponsor
- Integrity Applications Ltd.
Sepsis, Device Performance
PIVO Use for Blood Cultures in the Emergency Department
The investigators will implement a protocol for use of the PIVO device for blood culture collection in the emergency department.
- Conditions
- Sepsis, Device Performance, Emergency Medicine
- Trial name
- PIVO-ED (NCT07348289)
- Testing
- PIVO device, a needle-free blood draw device
- Where
- United States
- Volunteers
- 10,000 people
- Sponsor
- Intermountain Health Care, Inc.
Limb Length Discrepancy
Post-Market Study of the Ellipse PRECICE Intramedullary Limb Lengthening System
The purpose of this study is to obtain post market performance and safety data of the Ellipse PRECICE Intramedullary Limb Lengthening System for subjects undergoing unilateral limb lengthening.
- Trial name
- PINS (NCT01601301)
- Testing
- PRECICE System
- Where
- 6 sites in United States
- Volunteers
- 32 people
- Sponsor
- Ellipse Technologies, Inc.