Clinical trials: Device Performance
Diabetes
A Clinical Study to Collect Calibration & Performance Data of the KBS Systems 1.0 Non-Invasive Glucose Monitoring Device
The purpose of this study is to calibrate the performance of the KBS-1 non-invasive glucose monitoring device with diabetic people when compared to that of the standard method currently used in the clinical setting for…
- Trial name
- NCT03607435
- Testing
- Spectroscopy for Analyte Quantification
- Where
- United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Florida Hospital Tampa Bay Division
Device Validation of In-vivo Performance
An In Vivo 24-Hour Recovery Study of Whole Blood by the Reveos System
This is an in vivo 24-hour recovery study of leukoreduced red blood cells (RBCs) after automated separation of whole blood by the Reveos Automated Blood Processing System and storage for 42 days.
- Trial name
- NCT05239455
- Testing
- Reveos® Automated Blood Processing System
- Where
- 2 sites in United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Terumo BCT
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
Sleep Apnea
Evaluation of Compumedics "Somfit" Device
To study whether Somfit is substantially equivalent to an existing approved device (i.e. Compumedic's Grael System) to assist in elucidating sleep disorders.
- Trial name
- NCT04326127
- Testing
- Intervention is the validation of a sleep monitoring device (i.e. Somfit) against the gold-standard polysomnograph with electroencephalograph (i.e. the Greal system)
- Where
- Australia
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Compumedics Limited
Over Weight, Obesity
Safety and Performance Evaluation of Tulip Device in Healthy Overweight and Obese Volunteers
The study will assess the safety and performance of an intragastric auto-inflating and degradable balloon
- Trial name
- NCT01753609
- Testing
- Tulip capsule
- Where
- Israel
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Tulip Medical Ltd.
Measurement of Diathermy on Anatomical Locations of the Body
Sustained Acoustic Medicine Ultrasound Diathermy Clinical Performance
The purpose of this study is to measure diathermy performance of Sustained Acoustic Medicine Devices with commercially available ultrasound gel coupling patches.
- Trial name
- NCT05259995
- Testing
- Sustained Acoustic Medicine
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- ZetrOZ, Inc.
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
Hepatic Disease, Renal Disease
Assess Safety and Performance of the Kronos Electrocautery Device for Electrocautery Procedures Following Coaxial Biopsy Procedures
The primary objective for this study is to assess safety and performance of the Kronos Electrocautery Device for electrocautery procedures following coaxial biopsy procedures on areas that include, but are not limited to, liver…
- Trial name
- NCT05593211
- Testing
- Kronos Electrocautery Device
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Single Pass Inc
Tuberculosis (TB)
QuantiFERON Access Clinical Performance Study Protocol
Approximately 225 samples, obtained from participants with varying risk factors for TB infection and disease, will be tested using the QFT Access Kit and the comparator device QFT-Plus.
- Trial name
- NCT04243031
- Testing
- QFT Access
- Volunteers
- healthy volunteers welcome
- Sponsor
- QIAGEN Gaithersburg, Inc
Healthy Adult Participants
A Study of Subcutaneous Gefurulimab Using Prefilled Syringe Versus Autoinjector in Healthy Adult Participants
This study will evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, immunogenicity, and device performance of gefurulimab.
- Trial name
- NCT06208488
- Testing
- Gefurulimab PFS-SD, Gefurulimab AI
- Where
- 2 sites in Canada
- Volunteers
- 175 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Intubation; Difficult or Failed
Use of Alexa as a Cognitive Aid for Emergency Front Of Neck Access (FONA)
The aim of the study is to investigate whether a voice activated cognitive aid can improve performance in a simulated emergency front-of-neck access scenario.
- Trial name
- FONA-A (NCT05635773)
- Testing
- Use of Alexa Visual Cognitive aid
- Where
- United Kingdom
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
Concussion, Mild, Autonomic Nervous System
Acute Nerve Stimulation For Enhancing Human and Cognitive Performance
The goal of this clinical trial is to test a wearable device's effect on performance in tactical populations with a history of concussion.
- Conditions
- Concussion, Mild, Autonomic Nervous System, Cognitive
- Trial name
- NCT05675956
- Testing
- Experimental group with 100% intensity setting on Apollo Neuro device, Active Comparator group with 10% intensity setting on the Apollo Neuro device
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- University of South Carolina
Myopia
Performance of DAILIES TOTAL1 Daily Disposable Contact Lenses in Habitual Soft Lens Wearers Who Report Substantial Digital Device Use
The purpose of this study is to evaluate the performance of DAILIES TOTAL1 daily disposable contact lenses with regards to subjective symptoms (comfort, dryness, vision) in lens wearers who use identify themselves as substantial…
- Trial name
- FOX (NCT06308666)
- Testing
- Delefilcon A contact lenses
- Where
- Canada
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- University of Waterloo
Device Convenience, Device Performance
Use of Apple Vision Pro as Virtual Monitor for Diagnostic and Therapeutic Procedures
This study evaluates whether the Apple Vision Pro (AVP), a head-mounted display device, can be used as a virtual monitor for performing diagnostic and therapeutic procedures.
- Conditions
- Device Convenience, Device Performance, Surgeons' Rating, Ergonomics
- Trial name
- NCT07797556
- Where
- United States
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- The Methodist Hospital Research Institute
Malnutrition
Comparing Performance of Simplified Mid-Upper Arm Circumference Devices ("Click-MUACs") to Detect Acute Malnutrition
The Click-Mid-Upper Arm Circumference study aims to describe and compare the performance of a set of three simplified mid-upper arm circumference classification devices ("Click-MUAC") for use by mothers and caregivers to screen…
- Trial name
- NCT02833740
- Testing
- Click-MUAC prototype & regular MUAC tape
- Where
- Kenya
- Volunteers
- 345 people, healthy volunteers welcome
- Sponsor
- Action Contre la Faim
Physical Rehabilitation
Performance of the BioGaming Device (YuGo) in the Support of Physical Rehabilitation
The purpose of this study is to evaluate the movements performed according to the BioGaming YuGo software, and verify that they are rehabilitation movements.
- Trial name
- NCT02373748
- Testing
- BioGaming YuGo System
- Where
- Israel
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- BioGaming Ltd.
Blood Routine Examination
Performance Evaluation of In-Vitro Diagnostic Device
This is an interim report for POC testing of skyla Clinical Chemistry Analyzer and four skyla Test Systems (ALB, BUN, GLU, and TP). The analyses are performed with skyla Clinical Chemistry Analyzer.
- Trial name
- NCT02894762
- Where
- Taiwan
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Lite-On Technology Corporation H.S.P.B
Contraception
IUB(TM) SCu300B - Post Marketing Performance Study in Austria
Participating investigators will locate all IUB B insertions conducted at their facility at least 12 month prior the initiation of study data collection. The study is composed of 2 parts.
- Trial name
- NCT02778061
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Ocon Medical Ltd.
HIV Infections, Hepatitis C
Multicenter Performance Study of QuadQuik Invitro Diagnostic Device
To Demonstrate Clinical Performance of the TriQuik Invitro Diagnostic Device
- Conditions
- HIV Infections, Hepatitis C, Hepatitis B, Syphilis Infection
- Trial name
- NCT05692505
- Testing
- QuadQuik
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Genlantis Diagnostics
Abdominal Fat
VelaShape III Device in Comparison to Cryolipolysis for Circumferential Reduction
The purpose of this study is to compare the clinical performance of the VelaShape III device with CoolSculpt for reduction of the waist, love handles and flanks.
- Trial name
- NCT02143960
- Testing
- VelaShape III, CoolSculpt
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Syneron Medical