Clinical trials: Demonstrate Effectiveness of Virtual Simulator in Improving or Performance
- Condition Demonstrate Effectiveness of Virtual Simulator in Improving or Performance
- Funder type Industry (pharma, biotech, devices)
Asthma COPD
Clinical and Medico-economic Validation of the HEPHAI Solution.
In a context where the use of inhalation devices for respiratory medications is associated with a high frequency of critical errors, our primary hypothesis is that the use of the HEPHAÏ solution reduces this frequency compared to…
- Trial name
- VAL-HEPHAI (NCT06099145)
- Testing
- Hephaï
- Where
- 5 sites in France
- Volunteers
- 238 people
- Sponsor
- Hephai
Glut1 Deficiency Syndrome, De Vivo Disease
Early Diagnosis of the GLUT1 Deficiency Syndrome With a Blood Based Test
The study aims at validating the diagnostic performances of the METAglut1, a blood in vitro diagnostic test, for the simple and early diagnosis of the Glut1 deficiency syndrome (Glut1DS, or De Vivo disease).
- Conditions
- Glut1 Deficiency Syndrome, De Vivo Disease, Seizures, Movement Disorders
- Trial name
- METAglut1 (NCT03722212)
- Testing
- METAglut1
- Where
- 28 sites in France
- Volunteers
- 636 people
- Sponsor
- METAFORA biosystems
Liver Preservation
Trial of the TransMedics Organ Care System™ Liver For Preserving and Assessing Donor Livers for Transplantation
A prospective, single-center controlled trial to evaluate the safety and performance of the portable Organ Care System (OCS) Liver for preservation and assessment of donor livers for transplantation.
- Trial name
- REVIVE (NCT02449694)
- Testing
- OCS Liver
- Where
- United Kingdom
- Volunteers
- 25 people
- Sponsor
- TransMedics
Knee Reconstruction
Retro-prospective Study of Safety & Performance of Round XTENDOBUTTON™ Fixation Device Post Knee Repair
The 12 month post-operative study is designed to provide safety and performance data on the Round XTENDOBUTTON™ fixation device after knee repair.
- Trial name
- XTENDOBUTTON (NCT04211857)
- Testing
- Round XTENDOBUTTON Fixation Device used in suture fixation of ligaments and tendons in conjunction with an ULTRABUTTON™ product or ENDOBUTTON™ device.
- Where
- Australia
- Volunteers
- 40 people
- Sponsor
- Smith & Nephew, Inc.
Gastrointestinal Anastomosis
Safety, Tolerability and Performance Profile of the Colospan Device CG-100 in Patients Undergoing Colorectal Surgery
The purpose of this study is to evaluate the CG-100 device, a single use, temporary intraluminal bypass device,intended to reduce contact of fecal content with an anastomotic site, following colorectal surgery (open or…
- Trial name
- NCT02109991
- Testing
- CG-100 device
- Where
- 8 sites in Belgium, Croatia and 2 more
- Volunteers
- 60 people
- Sponsor
- Colospan Ltd.
Sleep Deprivation, Sleepiness
Shift Hours' Impact on Fatigue and Tracking of Eye Dynamics
The goal of this clinical trial is to learn how night shift-induced sleep debt affects oculomotor patterns, attentional state, and diagnostic performance in emergency radiologists.
- Conditions
- Sleep Deprivation, Sleepiness, Eye-Tracking Technology, Radiologists
- Trial name
- SHIFTED (NCT07192380)
- Testing
- Electroencephalogram, Actigraphy, Eye Tracking
- Where
- France
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- IMADIS Technologies et Services
ADHD
Amphetamine Extended Release Tablets and Driving Performance in Subjects With Attention Deficit/Hyperactivity Disorder (ADHD)
The purpose of this study is to assess the effect on driving performance of a single dose of amphetamine extended-release tablets (20 mg/tablet) compared with placebo at 45 minutes and 10 hours post-dose in young adults with ADHD.
- Trial name
- NCT04027361
- Testing
- Amphetamine Extended Release (ER) Tablet 20 mg
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- Tris Pharma, Inc.
Cardiac Arrhythmia
The Objective of This Multicentre Study is to Collect Operative Data on the Related Clinical Functional Outcomes and Complications and of Market Approved Alcis Electrophysiology Catheters to Demonstrate Safety and Performance of These Devices in a Real-world Setting
The objective of this multicentre study is to collect operative data on the related clinical functional outcomes and complications and of market approved Alcis electrophysiology catheters to demonstrate safety and performance of…
- Trial name
- NCT05314218
- Testing
- Electrophysiology catheters and cables
- Where
- 2 sites in France
- Volunteers
- 168 people
- Sponsor
- Alcis
Bacteremia
Study of the Performance of the KeyPath MRSA/MSSA Blood Culture Test - BTA
In vitro identification of S. aureus,methicillin-sensitive S. aureus (MSSA) and methicillin-resistant S. aureus (MRSA)from positive blood culture using MicroPhage's bacteriophage-based diagnostic platform.
- Trial name
- NCT01640886
- Where
- 3 sites in United States
- Volunteers
- 764 people
- Sponsor
- MicroPhage, Inc.
Abdominal Aortic Aneurysms
Treovance Stent-Graft With Navitel Delivery System for Patients With Infrarenal Abdominal Aortic Aneurysms
The primary goal of the study is to assess the safety and performance of the Treovance device in subjects with infrarenal aortic aneurysms, specifically to evaluate if the diseased pathology can be treated with an acceptable…
- Trial name
- NCT01328197
- Testing
- Treovance Abdominal Aortic Stent-Graft with Navitel Delivery System
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Bolton Medical
Dental Implants
Study Evaluating the Performance and Safety in the Medium and Long Term of Global D ZygoFixU System
Global D has developed an zygomatic implant prosthetic system (ZygoFixU range): zygomatic implants, prosthetic parts and associated instruments.
- Trial name
- NCT06960460
- Testing
- Dental implant surgery with ZygoFixU implants
- Where
- 3 sites in France, Italy
- Volunteers
- 99 people
- Sponsor
- Global D
Astigmatism
Clinical Performance of Habitual Hydrogel vs. Silicone Hydrogel Toric Contact Lenses
Evaluate the clinical performance of existing wearers of hydrogel toric lenses when refitted with Avaira toric silicone hydrogel contact lenses over 1 week of wear.
- Trial name
- NCT02142361
- Testing
- enfilcon A
- Where
- Spain
- Volunteers
- 60 people
- Sponsor
- CooperVision, Inc.
Chronic Pain
A Single Arm, Open-label First In Human Study for Assessing the Safety and Performance of the EpiFinder in Subjects With Clinical Indication for Lumbar Epidural Steroids Injection (ESI)
The EpiFinder device, which is the investigational device in this study, is intended for use in epidural procedures, between a luer syringe and an epidural needle, to give the treating physician a clear indication that the needle…
- Trial name
- NCT04047927
- Testing
- EpiFinder
- Where
- 2 sites in Israel
- Volunteers
- 15 people
- Sponsor
- Omeq Medical
Renal Failure, End Stage Renal Disease
Safety and Clinical Performance of a Dialyzer With a Modified Polysulfone Membrane
The clinical investigation will be performed to generate clinical data on clearances and removal rates (for ß2-microglobulin, myoglobin, phosphate, creatinine, and urea) as well as biocompatibility of the modified polysulfone…
- Trial name
- eMPORA (NCT03315624)
- Testing
- Dialyzer
- Where
- Germany
- Volunteers
- 49 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
Aortic Stenosis
U.S. Multicenter Feasibility Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
The goal of this clinical trial is to learn about the safety and performance of the F2 device for cerebral embolic protection in participants with symptomatic aortic stenosis undergoing a Transcatheter Aortic Valve replacement…
- Trial name
- NCT06069661
- Testing
- Aortic Stenosis
- Where
- United States
- Sponsor
- EnCompass Technologies, Inc.
Urinary Retention
A Confirmatory Study Confirming Performance of a New Intermittent Catheter
A multi-centre, randomized, controlled crossover design. The total study duration for the individual subject was approximately 9 weeks.
- Trial name
- NCT05485935
- Testing
- Investigational device - intermittent catheter with micro-hole zone, Comparator - standard intermittent catheter
- Where
- 6 sites in Denmark, France and 2 more
- Volunteers
- 73 people
- Sponsor
- Coloplast A/S
Xerostomia
Evaluation of an Electro-stimulator for the Treatment of Xerostomia
This is a multinational trial, aimed at testing the safety and performance of a electrostimulating device ("GenNarino") to treat dry mouth, over one year.
- Trial name
- GenNarino (NCT00509808)
- Testing
- Electrostimulation
- Where
- Finland
- Volunteers
- 200 people
- Sponsor
- Saliwell Ltd.
Narcolepsy, Excessive Sleepiness
Study Assessing Effects of JZP-110 on Driving Performance in the Treatment of Excessive Sleepiness in Narcolepsy
This trial is a randomized, double-blind, placebo-controlled, crossover study to evaluate the effect of JZP-110 on driving performance in subjects with excessive sleepiness due to narcolepsy.
- Trial name
- NCT02806908
- Testing
- JZP-110
- Where
- Netherlands
- Volunteers
- 24 people
- Sponsor
- Jazz Pharmaceuticals
Dental Malocclusion, Edentulous Mouth
Safety and Technical Performance of Plastalgin and Plastalgin Fast in Patients Requiring a Dental Impression
The aim of this study is to gather clinical data related to the use of Plastalgin and Plastalgin Fast, in order to comply with the new medical device regulation.
- Conditions
- Dental Malocclusion, Edentulous Mouth, Dental Misalignment
- Trial name
- NCT05614635
- Testing
- Plastalgin and Plastalgin Fast
- Where
- 2 sites in France
- Volunteers
- 59 people
- Sponsor
- Septodont
Aortic Stenosis
Feasibility Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
The goal of this clinical trial is to learn about the safety and performance of the F2 device for cerebral embolic protection in participants with symptomatic aortic stenosis underdoing a Transcatheter Aortic Valve replacement…
- Trial name
- NCT05866640
- Testing
- F2 filter and delivery system
- Where
- Georgia
- Volunteers
- 31 people
- Sponsor
- EnCompass Technologies, Inc.
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