N/A N=103 Transcutaneous Bilirubinometry in Neonates With Bilicare System
We Will Focus on Assessing the Clinical Performance of the BiliCare Device
Primary: BiliCare TcB Result Compared to TSB Result — 8.46; 7.93; 7.83 mg/dL
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=113 Transcutaneous Bilirubinometry in Neonates With the Bilicare System
Transcutaneous Bilirubinometry
Primary: In This Study, the Investigators Plan to Test the Performance of a Novel Transcutaneous Device (BiliCareTM) to Screen for Bilirubin Levels at Postnatal Age of 12 to 48…
N/A N=111 Transcutaneous Bilirubinometry in Neonates With the BiliCare System Compared to the Invasive TSB Test
We Will Focus on Assessing the Clinical Performance of the BiliCare Device
Primary: BiliCare TcB Result Compared to TSB Result — 8.0; 7.3 mg/dL
N/A N=203 BiliCam Clinical Validation Study
Newborn Jaundice
Primary: BCB - TSB Correlation — 0.82 correlation coefficient — p=<.001
N/A N=63 Novel Non-Invasive Monitoring Parameter in a Hospital Setting
Respiratory Insufficiency · Respiratory Failure
Primary: The Covidien Nellcor Respiration Rate Software Shall Determine Respiration Rate Measured as Mean and Standard Deviation With Accuracy That is Non-inferior to Predicate…
N/A N=430 Implementation of a Transcutaneous Bilirubinometer
Neonatal Jaundice · Hyperbilirubinemia
Primary: Number of Blood Tests for Bilirubin Measurement (Before the Potential Start of Phototherapy). — 0; 1 blood tests for bilirubin
N/A N=30 Evaluation of Performance, Usability, and Reliability of a Novel Device for Continuous Collection of Physiological Data
Healthy Normals
Primary: Accuracy of Heart Rate Measured in Beats Per Minute Compared to Reference Device — 2.0 beats per minute
N/A N=136 BD MiniDraw™ Capillary System Clinical Equivalence Study
Healthy · Disease, Chronic · Acute Disease
Primary: Chemistry Analytes [Albumin (ALB) and Total Protein (TP)] in Serum Measured Using the Silica Clot Activator for Serum Samples — 3.746; 3.787; 6.77; 6.83 g/dL
N/A N=94 Performance of an Investigational Blood Glucose Monitoring System in a Clinical Setting
Diabetes
Primary: Numbers of Fingerstick Blood Glucose (BG) Results Within +/- 5 to 20mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method — 180; 179; 172…
N/A N=94 A Comparative Clinical Trial of the TensorTip, a Novel Non Invasive Device for Measurement Blood Parameters
Anemia · Diabetes · Heart Disease
Primary: Comparison of the TensorTip Accuracy Against Hospital Periodical Readings. — 0.6; 7.9; 7.5; 2.33 percentage of error
N/A N=17,987 Abbott Laboratories Alinity s Blood Screening Assays - Clinical Evaluation Protocol
Healthy
Primary: Alinity s HBsAg Assay Specificity — 16985; 6; 2 Participants
N/A N=525 A Post-Market Clinical Trial to Evaluate the Performance and Operation of the Brevera Breast Biopsy System
Breast Cancer Female
Primary: Difference in Procedural Time in Minutes — 42.15; 40.13 procedure time in minutes
Phase 2 N=18 An Open Label Study to Assess the Effect of BLI800 on Safety and Clinical Chemistry Parameters
Colonoscopy · Bowel Preparation
Primary: Maximum Observed Concentration (Cmax) — 717.0; 499.5; 560.2 µmol/L
N/A N=16,388 Alinity s Anti-HCV II - Clinical Evaluation Protocol
Healthy
Primary: Assay Specificity Results for Participants (Specimens) Tested With Alinity s Anti-HCV II Assay. — 15,506; 6; 14 Specimen
N/A N=118 User Study of an Investigational Blood Glucose Monitoring System
Diabetes
Primary: Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15mg/dL (<75 mg/dL) or Within +/- 20% (>=75 mg/dL) of Laboratory Glucose Method — 115 BG test results
N/A N=42 Uro-NIRS Clinical Study
Lower Urinary Tract Symptoms · Overactive Bladder
Primary: Number of Participants Reporting Downward/Flat/Upward Patterns as Assessed by Near Infrared Spectroscopy (NIRS) for BOO Diagnosis — 9; 4; 13; 4 participants
N/A N=100 An Inpatient Performance Evaluation of a New Subcutaneous Glucose Sensor
Type 1 Diabetes Mellitus · Type 2 Diabetes Mellitus
Primary: Glucose Sensor Accuracy When Compared to Laboratory Standard (YSI): Proportion of Glucose Sensor Readings That Met Accuracy Criteria — 79.45 paired sensor and YSI…
N/A N=368 User Performance Evaluation for DARIO™ BGMS
Diabetes
Primary: Accuracy - Blood Glucose Level Obtained by Layperson With the Dario Meter Compared to Blood Glucose Level on Yellow Springs Instrument Obtained by Nurse/Technician — 12…
N/A N=412 FibroTouch Non-invasive Evaluation of Liver Fibrosis and Cirrhosis
Liver Fibrosis · Cirrhosis · Chronic Hepatitis B
Primary: The Clinical Value Evaluation of FibroTouch for Non-invasive Diagnosis of Liver Fibrosis in Patients With Chronic Hepatitis B by Using Liver Pathology as the Gold…
N/A N=247 Biolinq Safety and Effectiveness Trial
Diabetes · Diabetes Mellitus
Primary: In Target Color Indicator - Blue — 7494 Paired Samples - YSI to Biolinq
N/A N=77 Minimally Invasive Cardiac Output Monitoring Device
Cardiac Event
Primary: Establishment of a Dataset to Create an Algorithm to Measure Cardiac Output — 75; 2 Participants
N/A N=117 U-TruSignal SpO2 Testing in Neonates
Pulse Oximetry
Primary: Accuracy Root Mean Square (ARMS) Per Data Pair — 2.57; 2.57 percentage of oxygen saturated hemoglobi
N/A N=20 T-DOC® NXT Clinical Investigation
Incontinence, Urge
Primary: The Number of Patients in Which the T-DOC® NXT Catheters Are Safe in Measuring Urodynamic Pressure in Adults. — 20 Participants
N/A N=110 User Performance Evaluation of an Investigational Blood Glucose Monitoring System
Diabetes
Primary: Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/-15mg/dL(<75 mg/dL) or Within +/- 20% (>=75 mg/dL) of Laboratory Glucose Method — 110; 109; 109; 90…
N/A N=123 Clinical Performance Evaluation of Pefakit® PiCT® UC In Vitro Diagnostic Medical Device
Thromboembolic Events
Primary: Overall Sensitivity and Specificity of Pefakit and Hemosil. — 83.3; 77; 81.5; 59.3 percentage of cases
N/A N=35 Investigation of the Ability of the TENA SmartCare Change Indicator to Reduce the Number of Manual Checks Between Changes of Absorbing Incontinence Products
Urinary Incontinence
Primary: Number of Manual Checks Per Day at Baseline Week and 3 Weeks — 3.5; 4.3 Checks per day — p=0.0006
N/A N=15 Clinical Evaluation of the CM-1500 During Hemodialysis
Fluid Loss · Dialysis
Primary: Average Relative Index Value Following a Hemodialysis Procedure — 93.05 Relative Index (RI)
N/A N=27 Novel Non-Invasive Monitoring Parameter in Healthy Volunteers
No Conditions · Focus is Respiratory Rate
Primary: The Covidien Nellcor Respiration Rate Software Shall Determine Respiration Rate Measured as Mean and Standard Deviation With Accuracy That is Non-inferior to Predicate…
N/A N=2,379 Colorectal Polyp Clinical Decision Support Device Study
Polyp · Colorectal · Colonoscopy
Primary: Specificity and Sensitivity CDSD-unaided and CDSD-aided Endoscopist Predictions of Diminutive Polyp Histology — 90.8; 90.7; 64.7; 59.5 percentage of polyps
N/A N=220 Performance Evaluation of an Investigational Blood Glucose Monitoring System
Diabetes
Primary: Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method — 100 percentage of BG…