Clinical trials: Reliability
Tachyarrhythmia
Lead EvaluAtion for Defibrillation and Reliability (LEADR) / Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing (LEADR LBBAP)
The LEADR study is designed to assess the safety and efficacy of the Next Generation ICD lead. The LEADR LBBAP study is being conducted under the existing US FDA Investigational Device Exemption (IDE) for the Next Generation ICD…
- Trial name
- NCT04863664
- Testing
- Defibrillation (RV Implant), Defibrillation (LBBAP Implant)
- Where
- 55 sites in United States, Australia and 18 more
- Volunteers
- 998 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Arrhythmia, Bradycardia
MEDTRONIC ADAPTA, VERSA AND SENSIA nEw3 POST APPROVAL STUDY
The primary purpose of this study is to assess the long term reliability of the Medtronic Adapta®/Sensia™/Versa™ platform of devices. This study is required by FDA as a condition of approval of nEw3 devices.
- Trial name
- NCT01076374
- Where
- 129 sites in United States, Austria and 10 more
- Volunteers
- 2,927 people
- Sponsor
- Medtronic
Arrhythmia, Bradycardia
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
The main purpose of the Product Performance Report (formerly referred to as System Longevity Study) is to evaluate long-term performance of Medtronic market-released cardiac rhythm products by analyzing product survival…
- Conditions
- Arrhythmia, Bradycardia, Heart Failure, Sinus Tachycardia
- Trial name
- PPR (NCT00271180)
- Testing
- Device
- Where
- 333 sites in United States, Australia and 33 more
- Volunteers
- 20,000 people
- Sponsor
- Medtronic
Resting Metabolic Rate
A Systematic Review on the Accuracy and Reliability the BodyGem/MedGem Metabolic Devices
With the number of individuals becoming overweight or obese, healthcare professionals are in need of accurate, reliable, and convenient tools to help personalize weight loss programs. Recently, a new indirect calorimeter (i.e.
- Trial name
- NCT00502931
- Where
- United States
- Sponsor
- Microlife
Pain, Otitis Media
Study of FAECC Scale (Modified FLACC) to Evaluate Ear Pain in Children With Acute Otitis Media
This study is to assess the reliability and validity of the FAECC scale to evaluate pain associated with acute otitis media in children aged 2 months to 5 years.
- Trial name
- NCT01588535
- Testing
- benzocaine
- Where
- 15 sites in United States
- Volunteers
- 38 people
- Sponsor
- Arbor Pharmaceuticals, Inc.
Concussion
ImPACT Version 4-Touchscreen: Normative and Reliability Study
This research study is designed to establish normative database and reliability of ImPACT for adolescents and adults ages 12 through 80 to expand the use of devices to include touchscreen.
- Trial name
- NCT05551520
- Testing
- Normative, Reliability
- Where
- United States
- Volunteers
- 1,437 people, healthy volunteers welcome
- Sponsor
- ImPACT Applications, Inc.
Asthma, Chronic Obstructive Pulmonary Disease
Reliability of a Top Mount Actuation Indicator With Levalbuterol MDI in Adult and Pediatric Subjects With Asthma or COPD
This is a study to investigate the reliability, ruggedness and safety of the top mounted actuation indicator (TMAI) when used with Levalbuterol HFA MDI.
- Conditions
- Asthma, Chronic Obstructive Pulmonary Disease, COPD
- Trial name
- NCT00583986
- Testing
- Levalbuterol HFA MDI with top mounted actuation indicator
- Where
- 26 sites in United States
- Volunteers
- 150 people
- Sponsor
- Sumitomo Pharma America, Inc.
Alzheimer Disease
A Reader Study to Assess Accuracy and Reliability of Flortaucipir F 18 Positron Emission Tomography (PET) Scan Interpretation
This study will evaluate the performance of physician readers trained to read flortaucipir-PET (positron emission tomography) scans.
- Trial name
- NCT03901092
- Testing
- flortaucipir F 18
- Where
- United States
- Volunteers
- 242 people
- Sponsor
- Avid Radiopharmaceuticals
Alzheimers Disease
The Feasibility of Florbetapir Quantitation
The overall objective of the study is to assess the feasibility of implementing a quantitative process of florbetapir F 18 scan interpretation.
- Trial name
- NCT01946243
- Testing
- Florbetapir F18
- Where
- United States
- Volunteers
- 96 people
- Sponsor
- Avid Radiopharmaceuticals
Tachyarrhythmia
Lead Evaluation for Defibrillation and Reliability Post Approval Study
Medtronic is sponsoring the LEADR PAS to provide continuing evaluation and periodic reporting of safety and effectiveness of the OmniaSecure™ defibrillation lead following commercial release.
- Trial name
- LEADR PAS (NCT07005232)
- Testing
- defibrillation lead
- Where
- 73 sites in United States, Austria and 5 more
- Volunteers
- 2,000 people
- Sponsor
- Medtronic
Post Cardiac Surgery
Measure Cardiac Output Using Ultrasound Dilution in Mechanically Ventilated Children
The measurement of cardiac output (CO) and hemodynamic pressures are vital for proper management of severely hemodynamic compromised patients.
- Trial name
- NCT01662141
- Where
- Sweden
- Volunteers
- 33 people
- Sponsor
- Transonic Systems Inc.
Pregnancy; Habitual Aborter, Weeks of Gestation 37 or More
Accuracy and Reliability of Fetal Heart Rate and Uterine Contraction Monitoring Method
Clinical Investigation Protocol for a study designed to determine the equivalence of the Monica AN24 monitor to Philips 50XM for fetal heart rate (FHR) and uterine contraction (UC) monitoring during labor.
- Trial name
- NCT01280357
- Testing
- Monica AN24 (K101081), Philips 50XM
- Where
- 2 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Monica Healthcare Ltd
Dermatitis Atopic
A Study to Assess the Reliability/Feasibility of Using Emerald Touchless Sensor for Scratching and Sleep Quantification in a Subset of Participants From PEDISTAD Study (OBS15333; NCT03687359)
Primary objective: To explore and quantify the association between nighttime scratching and sleep patterns objectively in pediatric participants with moderate to severe atopic dermatitis (AD) using an innovative Emerald touchless…
- Trial name
- NCT05235724
- Where
- 7 sites in United States
- Volunteers
- 18 people
- Sponsor
- Sanofi
Clinical Documentation, Artificial Intelligence
Ambient Audio-Visual Capture for Clinical Documentation and Assessment
AI-powered tools that automatically document clinical conversations are being adopted rapidly in outpatient settings but have not been evaluated in hospital wards.
- Conditions
- Clinical Documentation, Artificial Intelligence, Surgical Education, Medical Education
- Trial name
- BLACKFRAME-AV- (NCT07649772)
- Testing
- BlackFrame ambient audio-visual capture platform
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- BlackFrame.ai
Covid19
Detection of SARS-CoV-2 in Nasopharyngeal Swabs by Using Multi-Spectral Screening System
The aim of this research is to use the Multi-Spectral method to measure the biomolecular fingerprint of the virus directly instead of the virus's RNA (RT-PCR) or the body's immune response (antibody) measurement methods to…
- Trial name
- NCT04860895
- Testing
- AP-23
- Where
- Turkey (Türkiye)
- Volunteers
- 4,400 people, healthy volunteers welcome
- Sponsor
- Fable Biyoteknoloji San ve Tic A.S