Clinical trials: Device Performance
Visual Field Defect, Peripheral, Visual Field Defect, Nasal Step
Patient Performance and Acceptance of Virtual Reality Visual Field Devices
The purpose of this research is to study the effectiveness and patient experience when measuring visual fields using virtual reality goggles.
- Conditions
- Visual Field Defect, Peripheral, Visual Field Defect, Nasal Step, Visual Field Defect, Paracentral Scotoma of Both Eyes
- Trial name
- NCT04786886
- Testing
- VIrtual Reality Visual Field Exam
- Where
- United States
- Volunteers
- 58 people
- Sponsor
- University of Miami
Hepatic Tumor
Multicenter Study to Evaluate a New Robotic Device for Image-guided Percutaneous Needle Placement
This study evaluates the safety and performance of a new robotic device in the treatment of hepatic thermoablation in adults. The new robotic device will be used in all patients.
- Trial name
- NCT04230642
- Testing
- The Quantum Surgical device
- Where
- 2 sites in France
- Volunteers
- 22 people
- Sponsor
- Quantum Surgical
Dyslexia
Evaluation of the Performance and Safety of a Medical Device Developed to Improve the Reading of Dyslexic Patients
The aim of this study is to evaluate the efficacy and safety of a new medical device on the improvement of reading skills of dyslexic patients.
- Trial name
- DysLight (NCT04157829)
- Testing
- Scintilling lamp, Classic lamp
- Where
- 4 sites in France
- Volunteers
- 33 people
- Sponsor
- SATT Ouest Valorisation
Refractive Errors, Accomodation
Study in Pediatric Volunteers of a Handheld Device Versus a Standard Diagnostic Device in Ophthalmic Refraction
This study is exploratory and examines whether the refraction results obtained from a novel optical device yields results similar to the ophthalmic refraction measurements obtained from an autorefractor in children.
- Conditions
- Refractive Errors, Accomodation, Diagnostic Self Evaluation
- Trial name
- NCT04955379
- Testing
- EQ103
- Where
- Israel
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- EyeQue Corp.
Diabetes
BGM and HbA1c POC Device Evaluation
This study aims to assess analytical performance of four BGMs and four HbA1c POC devices in comparison to suitable comparator or reference methods, with the view to evaluate performance in the hands of trained users, as well as…
- Trial name
- NCT06170515
- Testing
- CareSens N-Eco (i-Sens), • CareSens N-Premier (i-Sens), CodeFree (SD Biosensor), GlucoNavii GDH (SD Biosensor), Affinion (Abbott), HbA1c 501 (HemoCue), A1Care (iSens), DCA Vantage (Siemens)
- Where
- 3 sites in Cambodia, Colombia and 1 more
- Volunteers
- 910 people
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
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.
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
COVID-19
Bioaerosol Sampling Device (BSD) Clinical Study
The goal of this clinical trial is to learn about the bioaerosol sampling device (BSD) and how it can sample patient bioaerosols (breath) and patient's nares for the detection of COVID-19 viral particles in patients seeking to be…
- Trial name
- NCT06047067
- Where
- 6 sites in United States
- Volunteers
- 330 people, healthy volunteers welcome
- Sponsor
- Cantor BioConnect, Inc.
We Will Focus on Assessing the Clinical Performance of the BiliCare Device
Transcutaneous Bilirubinometry in Neonates With the BiliCare System Compared to the Invasive TSB Test
The primary objective of this study is to define the performance evaluation of BiliCare TcB device to the "gold standard" bilirubin tests.
- Trial name
- NCT02372071
- Testing
- BiliCare
- Where
- Israel
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- Gerium Medical
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
Diabetes Mellitus, Type 1
Pediatrics Owning Performance Study
A more convenient blood glucose monitoring system integrated with a responsive mobile health app may facilitate improved diabetes control in adolescent and young adult patients with Type 1 diabetes.
- Trial name
- POPS! (NCT03251846)
- Testing
- Pops! One personalized mobile platform
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Children's Hospitals and Clinics of Minnesota
Glaucoma
Patient Performance on Virtual Reality Visual Field Devices as Compared to Standard of Care
The purpose of this research is to study the effectiveness and patient experience when measuring visual fields using virtual reality goggles.
- Trial name
- NCT04994457
- Testing
- Virtual Reality Visual Field, Standard Automated Perimetry
- Where
- United States
- Volunteers
- 287 people, healthy volunteers welcome
- Sponsor
- University of Miami
Atrial Septal Defect, Patent Foramen Ovale
Post Market Registry of the CBSO
Multi centre, international, post market registry to monitor the clinical performance and safety of an atrial septal closure device with biodegradable framework in patients with clinically significant atrial septum defect (ASD)…
- Trial name
- CBSO Registry (NCT04105595)
- Testing
- Septal defect closure
- Where
- Germany
- Volunteers
- 6 people
- Sponsor
- atHeart Medical
Aortic Valve Insufficiency, Aortic Aneurysm
HAART Annuloplasty Device Valve Repair Registry
Multicenter US registry study to assess procedure success and long-term (10-year) performance of the HAART 200 and HAART 300 Aortic Annuloplasty Devices when used during aortic valve repair in a routine cardiovascular practice…
- Trial name
- NCT04035356
- Testing
- Aortic valve repair
- Where
- 5 sites in United States
- Volunteers
- 183 people
- Sponsor
- Biostable Science & Engineering
Dermatitis, Contact, Dermatitis
Post-Marketing Clinical Follow-Up Trial to Evaluate the Performance and Safety of the Medical Device 047 TD Dermatitis Cream in Adults and Children With Atopic and Contact Dermatitis Symptoms Confirmed by Clinical Parameters
The study aims to evaluate and confirm the performance of 047 TD Dermatitis cream in the improvement of eczematous dermatitis and contact dermatitis, throughout a reduction in disease severity and symptoms.
- Conditions
- Dermatitis, Contact, Dermatitis, Dermatitis, Chronic, Dermatitis, Eczematous
- Trial name
- NCT07056569
- Testing
- 047_TD Dermatitis cream twice a day for 28 days
- Where
- 3 sites in Italy
- Volunteers
- 90 people
- Sponsor
- Biokosmes Srl
Bowel Dysfunction
An Evaluation of Navina Mini, a New Trans-anal Irrigation (TAI) Device in Children and Adolescents
The study is designed to deliver further information on clinical benefit, patients' satisfaction, and perception of handling and to confirm safety of Navina Mini when used in children and adolescents.
- Trial name
- NCT06385249
- Testing
- Navina Mini
- Where
- Sweden
- Volunteers
- 27 people
- Sponsor
- Wellspect HealthCare
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
Pediatric, Fracture
Investigation Of Bioabsorbable Screws In Pediatric Orthopedic Surgery
This study is a prospective randomized controlled trial comparing the clinical outcomes of bioabsorbable screws to conventional metal screws in pediatric patients (aged 0 to 18) undergoing surgical fixation for trauma or elective…
- Conditions
- Pediatric, Fracture, Orthopedic Devices Associated With Misadventures, Surgical Instruments, Materials and Devices (Including Sutures), Patient Satisfaction
- Trial name
- NCT06429267
- Testing
- Bioabsorbable Screw, Metal/Titanium Screw
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Louisiana State University Health Sciences Center in New Orleans
Intracranial Embolism and Thrombosis, Postoperative Complications
TCD Detection of Gas and Solid Micro-Emboli in Patients Undergoing Coronary Artery Bypass Grafting (CABG): The Influence of Proximal Anastomosis Technique
The purpose of this study is to test the hypothesis that using three different techniques to anastomose coronary grafts to the aorta: partial occlusion, single cross clamp, or using the Heartstring anastomotic device, will change…
- Trial name
- NCT00294814
- Testing
- Proximal anastomosis using Heartstring anastomotic device
- Where
- Israel
- Volunteers
- 100 people
- Sponsor
- Rambam Health Care Campus
Gait, Hemiplegic, Quality of Life
Effect of Using a Lower Limb Robotic Device for Patients With Chronic Stroke
This study will investigate if a lower limb robotic device can be used in a community setting to increase the amount of physical activity that individuals undertake following stroke and consequently improve biomechanical…
- Conditions
- Gait, Hemiplegic, Quality of Life, Vascular Stiffness, Stroke
- Trial name
- NCT03104127
- Testing
- Alter G Bionic Leg, Normal therapy (physiotherapy)
- Where
- United Kingdom
- Volunteers
- 40 people
- Sponsor
- University of Winchester