Clinical trials: Demonstrate Effectiveness of Virtual Simulator in Improving or Performance
- Condition Demonstrate Effectiveness of Virtual Simulator in Improving or Performance
- Has posted results yes
Healthy
Clinical Performance of Masimo INVSENSOR00057 for Atrial Fibrillation Detection
This study is designed to validate the performance of Masimo INVSENSOR00057 in detecting atrial fibrillation. The noninvasive ECG measurements will be compared to results obtained from an FDA-cleared ECG monitor.
- Trial name
- NCT05476250
- Testing
- INVSENSOR00057
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Dry Eye Disease
Study of Safety and Performance of a Novel Ocular Lubricant in Subjects With Dry Eye Disease
The purpose of this study is to evaluate and demonstrate the efficacy and safety of an investigational ocular lubricant formulation in patients with mild to moderate dry eye disease (DED).
- Trial name
- NCT06444516
- Testing
- FID123300 ocular lubricant
- Where
- 9 sites in United States
- Volunteers
- 188 people
- Sponsor
- Alcon Research
COVID-19
Clinical Performance Evaluation of the Bio-Self™ COVID-19 Antigen Home Test
The purpose of this study is to evaluate the performance of the Bio-Self COVID-19 Antigen Home Test. The study will evaluate the accuracy (sensitivity and specificity) in a simulated home use environment when compared to a…
- Trial name
- NCT05334758
- Testing
- Bio-Self COVID-19 Antigen Home Test, Standard of Care COVID-19 Test, RT-PCR Test
- Where
- 3 sites in United States
- Volunteers
- 282 people, healthy volunteers welcome
- Sponsor
- BioTeke USA, LLC
Nasolabial Fold, Safety
A Study to Evaluate the Performance and Safety of GP0045 for Correction of Moderate to Severe Nasolabial Folds
This is a study to assess the performance and safety of GP0045 when injected in the nasolabial folds. There is an 18 months follow up period.
- Trial name
- NCT03300466
- Testing
- GP0045, Comparator
- Where
- Sweden
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Galderma R&D
Evaluate Performance of New Fundus Camera
Assessment of Prototype Hand-held Fundus Camera
This is the proof of concept study to evaluate the performance of an early stage prototype of a hand-held fundus camera.
- Trial name
- NCT01244412
- Where
- United States
- Volunteers
- 1 people, healthy volunteers welcome
- Sponsor
- University of Rochester
Bankart Lesions, SLAP Lesion
PMCF Study on the Safety, Performance and Clinical Benefits Data of the ToggleLoc™ 2.9mm and JuggerLoc™ in the Shoulder
The study is a multicenter, retrospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to collect data confirming safety, performance and clinical benefits of the…
- Conditions
- Bankart Lesions, SLAP Lesion, Acromioclavicular; Dislocation, Capsular Shift/Capsulolabral Reconstruction
- Trial name
- NCT05584553
- Testing
- ToggleLoc 2.9 mm soft tissue device, JuggerLoc soft tissue device
- Where
- 3 sites in United States, Spain
- Volunteers
- 214 people
- Sponsor
- Zimmer Biomet
Diamond Blackfan Anemia, Blackfan Diamond Syndrome
Pilot Phase I/II Study of Amino Acid Leucine in Treatment of Patients With Transfusion-Dependent Diamond Blackfan Anemia
This study will determine the safety and possibility of giving the amino acid, leucine, in patients with Diamond Blackfan anemia(DBA)who are on dependent on red blood cell transfusions.
- Conditions
- Diamond Blackfan Anemia, Blackfan Diamond Syndrome, DBA, Congenital Hypoplastic Anemia
- Trial name
- LeucineDBA (NCT01362595)
- Testing
- leucine
- Where
- 11 sites in United States
- Volunteers
- 55 people
- Sponsor
- Northwell Health
Healthy
Comparison of Rainbow INVSENSOR00001 and Control SpHb Disposable Sensor Performance During Hemodilution
This study involves comparison of the performance of two SpHb sensors in subjects that undergo a hemodilution procedure. The sensors' performance will be assessed by comparison of the measured hemoglobin values against reference…
- Trial name
- NCT03273166
- Testing
- INVSENSOR00001, Control SpHb sensor, Hemodilution
- Where
- United States
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Heart Failure
A Clinical Trial to Evaluate the HeartWare MVAD® System (MVAdvantage)
This multi-center, prospective, non-randomized, single-arm trial will investigate the safety and performance of the HeartWare® Miniaturized Ventricular Assist Device (MVAD®) system over 24 months in subjects with advanced heart…
- Trial name
- NCT01831544
- Testing
- HeartWare MVAD® System
- Where
- 11 sites in Australia, Austria and 3 more
- Volunteers
- 11 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Diabetes Mellitus
Performance of Contour Next® and Contour Plus Elite® BGMS in Arterial Blood Samples From Hospitalized Adults
The purpose of the study is to extend the intended use of two BGMSs to include testing of arterial blood by Health Care Professionals (HCP) in a clinical setting.
- Trial name
- NCT05449795
- Testing
- Device: Contour Next and Contour Plus Elite BGMS testing of arterial blood
- Where
- Australia
- Volunteers
- 120 people
- Sponsor
- Ascensia Diabetes Care
Abdominal Injury, Thoracic Diseases
A Post Market Study to Confirm the Safety and Performance of the Signia™ Stapling System.
The objectives of this prospective, two-arm, multicenter post-market study is to confirm safety and performance through the incidence of subjects reporting serious adverse device effects (ADEs) up to and including 30 days…
- Trial name
- NCT03515811
- Testing
- Signia™ Stapling System
- Where
- 11 sites in United States, Canada and 3 more
- Volunteers
- 136 people
- Sponsor
- Medtronic - MITG
Healthy
INVSENSOR00027 Clinical Performance Study
This study assesses the investigational sensor's (INVSENSOR00027) performance for detection of subjects' position and posture in bed, along with heart rate and respiratory rate.
- Trial name
- NCT03650192
- Testing
- INVSENSOR00027
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Presbyopia Correction
CLARITI (TM) 1-Day Multifocal Contact Lenses Performance and Acceptance Evaluation
A comparative evaluation of a newly marketed multifocal contact lens with a single vision contact lens when used with near vision spectacles. The evaluation was to quantify the difference between the two test corrections.
- Trial name
- NCT02147093
- Testing
- Test (multi-focal), Control (Sphere)
- Where
- United Kingdom
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Vision Care, Inc.
Hearing Loss, Hearing Loss, Conductive
Cross-sectional Evaluation of the Subjective Performance and Satisfaction With Ponto Sound Processors
The study is a non-interventional, observational, cross-sectional, study on users of Ponto sound processors. The purpose of this study is to evaluate subjectively assessed hearing performance and satisfaction with Oticon…
- Conditions
- Hearing Loss, Hearing Loss, Conductive, Hearing Loss, Unilateral
- Trial name
- BC112 (NCT05356221)
- Testing
- Ponto Sound processor
- Where
- United States
- Volunteers
- 170 people
- Sponsor
- Oticon Medical
Proximal Humeral Fracture, Proximal Tibia Fractures
PMCF Study on the Safety, Performance and Clinical Benefits Data of the Zimmer® Plates and Screws System
The study is a monocentric, retro- and prospective, 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 Zimmer® Plates…
- Conditions
- Proximal Humeral Fracture, Proximal Tibia Fractures, Diaphyseal Fracture
- Trial name
- NCT05215613
- Where
- Italy
- Volunteers
- 57 people
- Sponsor
- Zimmer Biomet
Breast Cancer, Tumors, Breast
Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography (ADAPT)
The aim of this recruitment plan (ADAPT-BX) is to collect image and technical data on both digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM), along with other subject data including histology results…
- Trial name
- ADAPT (NCT02324205)
- Testing
- DBT and FFDM
- Where
- 3 sites in United States, France
- Volunteers
- 196 people
- Sponsor
- GE Healthcare
Aortic Valve Disease
CarboMedics Top Hat vs St. Jude Medical Regent Valve Comparing Sizing and Hemodynamics
The purpose of this study is to compare the sizing and implant techniques between the CarboMedics Top Hat supra-annular valve and the St. Jude Medical Regent valve.
- Trial name
- NCT00619151
- Testing
- Top Hat, Regent
- Where
- 2 sites in United States
- Volunteers
- 2 people
- Sponsor
- Sorin Group USA, Inc.
Retention, Urinary
Investigation of Non-CE Marked Intermittent Catheters for Females
Investigation of novel non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters for females with a comparator catheter.
- Trial name
- NCT04557787
- Testing
- SpeediCath® Standard female, New intermittent Variant 1 catheter for females, New intermittent Variant 2 catheter for females
- Where
- Denmark
- Volunteers
- 15 people
- Sponsor
- Coloplast A/S
COVID-19
Q-POC SARS-CoV-2 Assay COVID-19 Clinical Evaluation
Q-POC SARS-CoV-2 moderate complexity PCR test performance evaluation
- Trial name
- NCT05614011
- Testing
- RT-PCR Test, Real-time PCR Test
- Where
- 3 sites in United States
- Volunteers
- 877 people
- Sponsor
- QuantuMDx Group Ltd
Non Small Cell Lung Cancer, 4D CT
An Outcome Analysis for Stereotactic Body Radiation Therapy (SBRT) Treatment of Non-Small Lung Cancer Patients Using 4D PET/CT With Real-Time Position Management (RPM™) System and a Concomitant Evaluation of the Impact and Performance Characteristics of the Immobilization System
The goals of this clinical research are to evaluate the outcomes and tumor response for early stage non-small lung cancer (NSCLC) patients undergoing Stereotactic Body Radiation Therapy (SBRT) using four dimensional (4D) Positron…
- Trial name
- NCT02067858
- Testing
- Stereotactic Radiosurgery
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Steven Burton