Clinical trials: Performance Assessment
Brain Tumor Adult, Epilepsy
WISE Cortical Strip for Intraoperative Neurophysiological Monitoring
The WIN Study is a prospective, interventional, multi-center, open-label premarket study designed to confirm the safety, performance and intended use of the WISE Cortical Strip (WCS) for CE certification purposes.
- Trial name
- WIN (NCT03731455)
- Testing
- WISE Cortical Strip
- Where
- 5 sites in Germany, Italy and 1 more
- Volunteers
- 32 people
- Sponsor
- Wise S.r.l.
Knee Osteoarthritis, Knee Arthritis
Performance of MOTO Medial® Unicompartmental Knee Arthroplasty
This is a prospective, multi-center study, designed to assess mid-term performance of the MOTO Medial® Unicompartmental Knee Arthroplasty (UKA), with patient report outcomes, clinical findings and radiographic analysis.
- Conditions
- Knee Osteoarthritis, Knee Arthritis, Knee Pain Chronic
- Trial name
- NCT03211663
- Testing
- MOTO Medial® UKA
- Where
- 5 sites in United States
- Volunteers
- 269 people, healthy volunteers welcome
- Sponsor
- Medacta USA
Dyslexia
Evaluation of the Performance and Safety of the Atoldys/ Lexilens Glasses Developed to Improve the Reading of Dyslexic Subjects
The aim of this study is to evaluate the efficacy and safety of a new medical device (Atoldys/ Lexilens glasses) on the improvement of reading skills of young dyslexic subjects.
- Trial name
- NCT04586621
- Where
- 3 sites in France
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- ABEYE
Arterial Embolization
Prospective Study to Assess the Safety and Performance of the Easyx Antia Liquid Embolic in Intracranial Interventions
The study is a prospective, multicenter, multinational study to assess the safety and performance of the Easyx (trade name) Antia Liquid Embolic during embolization of intracranial malformations and fistulas.
- Trial name
- Ideale (NCT02863133)
- Testing
- Liquid Embolic
- Volunteers
- 65 people
- Sponsor
- Antia Therapeutics AG
Pulmonary Embolism, Venous Thromboembolism
Evaluation of the Short and Long Term Performance and Clinical Outcomes of the Crux Vena Cava Filter System
The Crux Vena Cava Filter (VCF) Registry is a clinical study, sponsored by Volcano Corporation, to evaluate the short and long term performance and clinical outcomes of the Crux Vena Cava Filter System.
- Conditions
- Pulmonary Embolism, Venous Thromboembolism, Deep Vein Thrombosis
- Trial name
- NCT02420626
- Where
- 3 sites in United States
- Sponsor
- Volcano Corporation
Depressive Disorder, Major
A Study of Oral Seltorexant as an add-on Medication to an Antidepressant on On-road Driving Performance in Participants With Major Depressive Disorder
The purpose of the study is to evaluate the effect of seltorexant, compared to placebo, as an add-on medication to an antidepressant, on next-day driving performance as assessed by the mean difference of standard deviation of…
- Trial name
- NCT04451187
- Testing
- Seltorexant Dose 1, Seltorexant Dose 2, Zopiclone
- Where
- 2 sites in Belgium, Germany
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Bradycardia, Atrial Tachyarrhythmia
AdvisaTM IPG Clinical Evaluation Study
The purpose of the Advisa IPG clinical study is to evaluate the overall system safety and clinical performance of the Advisa DR Implantable Pulse Generator (IPG).
- Trial name
- NCT00839384
- Testing
- Advisa IPG
- Where
- Czechia
- Volunteers
- 79 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Degenerative Disc Disease, Spine Fusion
MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion
This is a phase IV post-marketing study for MagnetOs Flex Matrix. MagnetOs Flex Matrix is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease and…
- Conditions
- Degenerative Disc Disease, Spine Fusion, Leg Pain and/or Back Pain
- Trial name
- PRECISE (NCT05037968)
- Testing
- MagnetOs Flex Matrix, Trinity Elite
- Where
- 9 sites in United States
- Volunteers
- 100 people
- Sponsor
- Kuros Biosurgery AG
Tooth Restoration
Evaluation of Self-adhesive Hybrid Resin Composite Compared to a Traditional Composite Resin in Restorations of NCCLs
This is a split-mouth randomized clinical investigation conducted to evaluate clinical performances of a self-adhesive hybrid resin composite (investigational medical device Surefil) compared to a traditional composite resin…
- Trial name
- NCT05751382
- Testing
- Surefil one, Venus Pearl
- Where
- Italy
- Volunteers
- 16 people
- Sponsor
- Dentsply Sirona Implants and Consumables
Cardiac Arrhythmia
An Evaluation of the Safety and Performance of the CathVision Cube® System
The primary objective is to evaluate the safety and technical performance of the CathVision Cube® System. The secondary objective is to benchmark the intracardiac electrogram signal quality compared to commercially available…
- Trial name
- NCT05114382
- Testing
- EP Procedure
- Where
- 2 sites in Czechia, Denmark
- Volunteers
- 24 people
- Sponsor
- CathVision ApS
Amyotrophic Lateral Sclerosis (ALS)
A Study to Evaluate the Performance of a Diagnostic Test in ALS
Prospective multicenter study of subjects who were recently diagnosed with amyotrophic lateral sclerosis (ALS) or another neurodegenerative disease (including spinal cord diseases, muscle diseases and neurological diseases such…
- Trial name
- NCT02759913
- Testing
- Lumbar puncture
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Iron Horse Diagnostics, Inc.
Dry Eye
Evaluation of the Performance of MAF-1217 on Cataract Surgery
MAF-1217 is meant as the medical device which is to be effective in most forms of DED; therefore, it is expected that study patients benefit from study participation, and can reduce the signs and symptoms of surgery induced DED…
- Trial name
- NCT03833908
- Testing
- MAF-1217
- Where
- 2 sites in Italy
- Volunteers
- 46 people
- Sponsor
- VISUfarma SpA
Refractive Errors, Myopia
Clinical Performance Assessment of Two Silicone Hydrogel Daily Disposable Contact Lenses
The purpose of this study is to assess the overall clinical performance of a contact lens made with a modified manufacturing process.
- Trial name
- NCT05725317
- Testing
- LID220365 contact lens, LID006961 contact lens
- Where
- 7 sites in United States
- Volunteers
- 114 people
- Sponsor
- Alcon Research
Aortic Valve Stenosis, Aortic Valve Calcification
Safety and Performance of TAVI of Venus MedTech Aortic Valve Prosthesis
1. objectives Evaluate the performance of Venus MedTech aortic valve prosthesis intervention by femoral artery Evaluate safety and clinical benefit of percutaneous implantation of the Venue MedTech aortic valve prosthesis.
- Trial name
- Venus-A (NCT01683474)
- Testing
- Venus MedTech Aortic Valve Prosthesis
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Venus MedTech (HangZhou) Inc.
Hepatitis C
Clinical Performance Evaluation of DxN HCV Assay
The DxN Hepatitis C Virus (HCV) Assay is an in vitro diagnostic assay intended as an aid in the management of of HCV-infected individuals undergoing antiviral therapy.
- Trial name
- NCT03125408
- Testing
- HCV Assay
- Where
- United States
- Volunteers
- 210 people
- Sponsor
- Beckman Coulter, Inc.
Ileostomy - Stoma
Investigating the Performance of a New Adhesive Strip
This study investigates the performance of a new adhesive
- Trial name
- NCT03423134
- Testing
- New adhesive strip
- Where
- Denmark
- Volunteers
- 6 people
- Sponsor
- Coloplast A/S
Peripheral Arterial Disease
BIOLUX P-III BENELUX All-Comers Registry
The purpose of the BIOLUX P-III BENELUX Registry is to further investigate the safety and clinical performance of the Passeo-18 Lux Drug Coated Ballon when used in daily clinical practice for the treatment of isolated…
- Trial name
- NCT03052309
- Testing
- Passeo-18 Lux DCB
- Where
- 9 sites in Belgium, Luxembourg and 1 more
- Volunteers
- 106 people
- Sponsor
- Biotronik AG
Healthy Subjects
A Three-phase Study That Will Compare the ECG Data Recorded Using the Test Device With the Data Recorded by a Reference Device, Evaluate the ECG Signal Quality of the Test Device Over a 10-day Simulated Use Period, and Assess the Effects of Variable ECG Electrode Placement for the Test Device
This clinical study will be performed in three phases. The purpose of Phase 1 of this study is to compare the ECG data recorded using the ZywieZ3 Sensor and ZywieZ3 Adhesive ("Test Device") to the data recorded by a traditional…
- Trial name
- NCT07200232
- Testing
- Phase 1 Test Device Sensor and Adhesive and Reference Device, Phase 2 Test Device ECG Signal quality over a 10-day simulated use period, Test Device Sensor and Adhesive Variable Placement
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Zywie, Inc.
Performance of Synthetic Polyurethane Male Condom
Clinical Study to Evaluate the Performance of Synthetic Polyurethane Male Condoms
This study is a randomized, double-blinded, crossover and multi-center study to evaluate the clinical breakage and slippage of a new synthetic polyurethane male condom compared to a commercially available standard latex condom.
- Trial name
- NCT05536336
- Testing
- Condom
- Where
- 4 sites in United States
- Volunteers
- 188 people, healthy volunteers welcome
- Sponsor
- Okamoto Industries, Inc.
Ovarian Cancer, Cervical Cancer
Sirius in Gynaecological Laparoscopic Surgery
Precision Robotics' Sirius Robotic Flexible Endoscopic System is a new fully integrated compact 3D laparoscopic camera system with a disposable single-use flexible tip that can change its viewing direction.
- Conditions
- Ovarian Cancer, Cervical Cancer, Gynecologic Cancer
- Trial name
- NCT05048407
- Testing
- Gynaecological laparoscopic surgery (Sirius System)
- Where
- Hong Kong
- Volunteers
- 30 people
- Sponsor
- Precision Robotics (Hong Kong) Limited