Clinical trials: Performance
Hydrocephalus
Safety and Performance of the Polaris® 24 Adjustable Valve System in Hydrocephalus Patients' Treatment
The SAPPHYRE study is an ambispective (retrospective and prospective) PMCF study with the objective to evaluate the safety and performance of the Polaris® 24 adjustable valve system in the treatment of 126 patients with…
- Trial name
- SAPPHYRE (NCT04746625)
- Where
- 2 sites in France
- Volunteers
- 126 people
- Sponsor
- Sophysa
Knee Injuries and Disorders, Shoulder Disease
C Scope Visualization System Prospective Study
Evaluation of the performance and safety of the C Scope Visualization System
- Conditions
- Knee Injuries and Disorders, Shoulder Disease, Shoulder Injuries
- Trial name
- NCT05153863
- Testing
- C Scope Visualization System
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- CIT Ortho
Diaper Rash
Multicenter, National, Observational, Prospective, Real-life Study Evaluating the Performance of 2% Aqueous Eosin in Children With Diaper Rash
This study is being conducted to provide updated clinical data on safety and performance (demonstrated previously for CE marking under the Medical Devices Directive) Cooper Aqueous Eosin 2%.
- Trial name
- EA2 (NCT05599763)
- Where
- France
- Volunteers
- 67 people
- Sponsor
- Cooperation Pharmaceutique Francaise
Compliance, Patient
Explorative Clinical Study on the Performance and Acceptance of New Intermittent Catheters in Healthy Volunteers
Performance and acceptance of new intermittent catheters tested in healthy volunteers
- Trial name
- NCT04231149
- Testing
- Test product 2, Test product 3, Comparator
- Where
- Denmark
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Coloplast A/S
Pulmonary Hypertension
Acute Assessment of the Aria CV System in Patients With WHO Groups 2 and 3 Pulmonary Hypertension
This study is a prospective, non-randomized, two arm, single-center acute feasibility study assessing safety and performance of the Aria CV Acute PH System in WHO Group 2 and 3 PH patients.
- Trial name
- NCT05001711
- Testing
- Aria CV Acute PH System
- Where
- Austria
- Volunteers
- 18 people
- Sponsor
- Aria CV, Inc
Influenza A, Influenza B
Validation of the Ellume® Respirio Flu Test and the Ellume® eLab Flu Test for the Rapid Identification of Influenza A/B
The primary purpose of this study is to validate the sensitivity and specificity of the Respirio Flu Test and the eLab Flu Test in detecting Influenza A as compared to the gold standard for detection, Reverse Transcriptase…
- Trial name
- NCT02767414
- Testing
- Respirio Flu Test, eLab Flu Test, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
- Where
- 7 sites in Australia
- Volunteers
- 1,500 people
- Sponsor
- Ellume Pty Ltd
Atrial Fibrillation, Tachycardia
Electrocardiographic Diagnostic Performance of the Apple Watch Augmented With an Artificial Intelligence Algorithm
The SWAF study will compare the performance of a smartwatch combined with Cardiologs Platform algorithm in the detection of Atrial Fibrillation and other arrhythmias with that measured on a manually read 12-lead ECG in subjects…
- Conditions
- Atrial Fibrillation, Tachycardia, Bradycardia, Premature Supraventricular Beat
- Trial name
- NCT05167058
- Testing
- Cardiologs Platform
- Where
- 3 sites in United States
- Volunteers
- 220 people
- Sponsor
- Cardiologs Technologies
Liver Transplantation
Study to Evaluate Performance of the Organ Recovery Systems LifePort® Liver Transporter System, a Machine Perfusion System, for Liver Transplant
Comparison of hypothermic machine perfusion of livers to standard of care (static cold storage).
- Trial name
- PILOT™ (NCT03484455)
- Testing
- Hypothermic machine perfusion, Static cold storage
- Where
- 9 sites in United States
- Volunteers
- 142 people
- Sponsor
- Organ Recovery Systems, Inc.
Aortic Valve Disease
Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve/ The SAPIEN 3 Study
The purpose of this study is to assess the safety and device success of the Edwards SAPIEN 3 Transcatheter Heart Valve (S3 THV) and the Edwards Commander and Certitude Delivery Systems in patients with symptomatic, severe aortic…
- Trial name
- SAPIEN3 (NCT01808287)
- Testing
- Edwards SAPIEN 3 Transcatheter Heart Valve
- Where
- 17 sites in Canada, France and 3 more
- Volunteers
- 250 people
- Sponsor
- Edwards Lifesciences
Prosthesis User, Prosthesis
Optimize Pattern Recognition Control of Powered Upper Limb Prosthesis
This study is focused on optimizing methods for controlling upper-limb myoelectric prosthetic arms. If you are enrolled in this study you would be expected to visit one of the research sites for approximately 5 in-lab visits…
- Conditions
- Prosthesis User, Prosthesis, Prosthetic, Upper Limb Amputation
- Trial name
- NCT07850544
- Testing
- Condition A: Electrode Configuration, Condition B: Electrode Configuration, Condition C: Electrode Configuration
- Where
- 2 sites in United States
- Volunteers
- 32 people
- Sponsor
- Liberating Technologies, Inc.
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
Condom Use
Evaluation of the Performance and Acceptability of a Synthetic Polyisoprene Male Condom Compared to a Natural Rubber Latex Condom
This study is a masked (investigators, research staff), two-way crossover, randomized to sequence of use study designed to evaluate the acceptability and functional performance (breakage, slippage) of a silicone lubricated…
- Trial name
- NCT06595836
- Testing
- Silicone Lubricated Synthetic polyisoprine condom, Silicone Lubricated Natural Rubber Latex Condom
- Where
- 2 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Thai Nippon Rubber Industry Public Company Limited
Lumbar Disc Herniation
Barricaid EU Post Market Study for Primary Lumbar Disc Herniation
The purpose of this multi-center post marketing surveillance study is to monitor the safety and performance of the Barricaid® ARD when used to surgically reconstruct the anulus of the L1 - S1 spinal disc.
- Trial name
- NCT01534065
- Testing
- Barricaid
- Volunteers
- 45 people
- Sponsor
- Intrinsic Therapeutics
Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men, Hot Flashes
A Study to Learn if Elinzanetant Affects the Ability to Drive and Brain Function in Healthy Women
Researchers are looking for a better way to treat vasomotor symptoms (VMS), also known as hot flashes. Hot flashes are intense and sudden feelings of heat along with sweating and reddening of the skin.
- Trial name
- NCT06219902
- Testing
- Elinzanetant (BAY3427080), Zopiclone
- Where
- Canada
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Bayer
Kidney Diseases, Kidney Injury
A Bioequivalence and Efficacy Study of MB-102 (Relmapirazin) in Chinese Participants
Part I (bioequivalence) will evaluate the bioequivalence of the Oversea Manufactured Sample (used in the MediBeacon Phase 3 Study 100-103; NCT05425719) and Domestic Manufactured Sample in Single Intravenous Dose of MB-102…
- Conditions
- Kidney Diseases, Kidney Injury, Kidney Failure
- Trial name
- NCT05943977
- Testing
- MB-102 DMID, MB-102 OMID, MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)
- Where
- 2 sites in China
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Motion Sickness, Space, Motion Simulation
Combination of Intranasal Scopolamine and Sensory Augmentation to Mitigate G-transition Induced Motion Sickness and Enhance Sensorimotor Performance
The primary specific aim of this Field Test aim is to evaluate the feasibility and efficacy of administering the intranasal scopolamine gel in operational field settings using both astronaut and ground-control subjects that are…
- Conditions
- Motion Sickness, Space, Motion Simulation, Parabolic Flight
- Trial name
- NCT05852730
- Testing
- DPI-386 Nasal Gel, Other (e.g., promethazine, meclizine)
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Repurposed Therapeutics, Inc.
Pregnancy
This Clinical Study Evaluates the Performance and Safety of Biorithm Research Kit Versus CTG in Prenatal Monitoring of Pregnant Participants.
This clinical study will evaluate the safety and comparative performance of Biorithm Research Kit vs CTG (gold standard) in prenatal monitoring of pregnant participants.
- Trial name
- NCT04941534
- Where
- United Kingdom
- Volunteers
- 100 people
- Sponsor
- Biorithm Pte Ltd
Vascular Access Complication
AccuCath™ Intravenous (IV) Device Used by Vascular Access Team (VAT)
The study will test a hypothesis that the AccuCath™ System will have a higher rate of successful first attempt peripheral intravenous (PIV) placement, higher completion of therapy, fewer complications, longer dwell times, and…
- Trial name
- NCT01937195
- Testing
- AccuCath Intravenous Catheter System
- Where
- United States
- Volunteers
- 95 people
- Sponsor
- C. R. Bard
Cervical Disc Degeneration
Real World Data Collection on the Synergy Cervical Disc
This trial is a real world data (RWD) collection observational study, comprised of both prospective and retrospective arms, that will examine the safety and effectiveness of the Synergy Cervical Disc System in patients with…
- Trial name
- NCT05305430
- Testing
- Synergy Cervical Disc System
- Where
- Australia
- Volunteers
- 200 people
- Sponsor
- Synergy Spine Solutions
Sjogren Syndrome
Intra-Nasal Mechanical Stimulation (INMEST) as a Potential Treatment Method for Sjogren's Syndrome (SS)
The purpose of the study is to investigate the effect and safety of the Walther System delivering INMEST (intranasal mechanical stimulation) on people with Sjogren\'s syndrome.
- Trial name
- A-SS-001 (NCT06626477)
- Testing
- Intra nasal mechanical stimulation treatment (INMEST)
- Where
- Sweden
- Volunteers
- 26 people
- Sponsor
- Abilion Medical Systems AB