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)
Arthroplasty, Arthroplasty Replacement, Knee
oneKNEE - Prospective, Non-interventional, Multicenter PMCF-Study
Safety and Clinical Performance in terms of clinical outcome of oneKNEE® (total knee arthroplasty TKA), evaluated 2 years after implantation.
- Conditions
- Arthroplasty, Arthroplasty Replacement, Knee, Prosthetic Joint Infections of Knee, TKA Outcomes
- Trial name
- oneKNEE (NCT07682909)
- Testing
- oneKNEE®
- Volunteers
- 1,020 people
- Sponsor
- Aesculap AG
Covid19, RSV Infection
Sample Collection Study to Aid Evaluation of an Influenza A/B, Respiratory Syncytial Virus & COVID-19 Virus POC Test
Collection of Nasal Swabs, Throat Swabs and Saliva Samples from patients presenting at their designated care or testing facility displaying symptoms of either Influenza, Respiratory Syncytial Virus (RSV), SARS-CoV-2 or those who…
- Conditions
- Covid19, RSV Infection, Influenza Type A, Influenza Type B
- Trial name
- INFORM (NCT04782336)
- Testing
- Sample Collection
- Where
- 6 sites in United Kingdom
- Volunteers
- 79 people
- Sponsor
- LumiraDx UK Limited
Peripheral Arterial Disease
BIOLUX P-III SPAIN All-Comers Registry
The purpose of the BIOLUX P-III Spain registry is to further investigate the safety and clinical performance of the Passeo-18 Lux Drug Coated Balloon in the treatment of long atherosclerotic femoropoliteal artery lesions in daily…
- Trial name
- NCT03052296
- Testing
- Passeo-18 Lux DCB
- Where
- 5 sites in Spain
- Volunteers
- 44 people
- Sponsor
- Biotronik AG
Hepatolenticular Degeneration; Wilson
Performance and Safety of MEX-CD1 Low-volume Continuous Veno-venous Haemodialysis Medical Device for Copper-extraction in Patients With Wilson's Disease
The goal of this clinical trial is to test the MEX-CD1 hemodialysis medical device in patients suffering from Wilson's Disease. The main questions it aims to answer are: Does the device work as expected by removing the excess of…
- Trial name
- MEXWILS (NCT05917327)
- Testing
- Low-volume continuous veno-venous haemodialysis
- Where
- 4 sites in France, Spain
- Volunteers
- 1 people
- Sponsor
- Mexbrain
Refractive Errors, Astigmatism
Study of a Hand-held Device Plus Mobile App Versus Standard Eye Care Devices in Measuring Refractive Error of the Eye
Single-center, open-label, prospective study in healthy volunteers desiring refraction for correction of visual acuity to compare a handheld device supported by a mobile application with the phoropter and autorefractor.
- Trial name
- NCT03929588
- Testing
- Hand-held device supported by a mobile application, Phoropter, Autorefractor
- Where
- United States
- Volunteers
- 230 people, healthy volunteers welcome
- Sponsor
- EyeQue Corp.
Chronic Pain
Validating and Evaluating the Pain Medicine Digital Workflow Algorithm (PGS 1.0)
This is a prospective, non-randomized, double blind, single center, single arm, validation study, to evaluate the performance of PGS 1.0 algorithm in analyzing pain specific symptoms and medical history data of pain patients…
- Trial name
- NCT07195162
- Where
- Israel
- Volunteers
- 200 people
- Sponsor
- PG Medical Systems Ltd.
Atrial Fibrillation
Safety and Performance of the SpherePVI™ Catheter to Treat Paroxysmal Atrial Fibrillation
A prospective, single-arm, single-center study to evaluate the safety, performance, and effectiveness of the SpherePVI™ Catheter for treating paroxysmal AF.
- Trial name
- SpherePVI (NCT05144503)
- Testing
- SpherePVI™ Catheter
- Where
- Lithuania
- Volunteers
- 100 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Prostate Cancer, Urology
A Single-arm, Multicenter Prospective Study to Evaluate the Diagnostic Performance of PROSTest in Men With PSA ≥ 3ng/ml Using Biopsy as the Sole Ground Truth
This prospective observational study will enroll men referred for prostate biopsy due to elevated PSA and/or abnormal digital rectal examination, with or without pre-biopsy MRI.
- Conditions
- Prostate Cancer, Urology, Prostate Cancer (Diagnosis)
- Trial name
- PROSTest_STRAT (NCT07454603)
- Testing
- PROSTEST
- Where
- United States
- Volunteers
- 1,500 people
- Sponsor
- Wren Laboratories LLC
Ischemic Heart Disease
Safety and Clinical Performance of the Yukon Choice PC, Yukon Chrome PC & Yukon Choice Flex Stents in Routine Practice
The goal of this observational study is to collect safety and performance information in the setting of a large-scale clinical registry.
- Trial name
- e-Yukon (NCT05703646)
- Where
- United Arab Emirates
- Volunteers
- 5,000 people
- Sponsor
- Translumina GmbH
Mechanically Ventilated Patients
Pilot Clinical Investigation to Evaluate a Prototype of Sensor Measuring Ventilator-derived Parameters
Recently, the threat of viral pandemics (Covid-19, severe acute respiratory syndrome, avian flu H5N1, and H1N1), which might result in thousands of patients requiring mechanical ventilation, has accelerated the need for…
- Trial name
- NCT06054503
- Testing
- prototype of sensor
- Where
- France
- Volunteers
- 59 people
- Sponsor
- Archeon
Cardiovascular Risk
Precision Study of CLAiR AI Software
This multi-site precision study evaluated the performance and reproducibility of the CLAiR artificial intelligence (AI) software in identifying elevated risk of atherosclerotic cardiovascular disease (ASCVD) from retinal fundus…
- Trial name
- NCT07747233
- Testing
- CLAiR Artificial Intelligence Software
- Where
- 2 sites in United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Toku Eyes Ltd
Gonarthritis, Degenerative Disease
Clinical Performance and Safety of the Unicompartmental Univation® XF Pro Implant
The study is designed as a prospective, observational, mid-term, multi-center follow-up study. It is planned to include 150 patients from 4 different study centres in Germany.
- Trial name
- UNI_XF_PRO (NCT06657248)
- Testing
- univation® XF Pro
- Where
- 4 sites in Germany
- Volunteers
- 150 people
- Sponsor
- Aesculap AG
Peripheral Intravenous Catheters
RIGHT IV Pilot Study
The purpose of this pilot study is to collect the necessary information for determining the appropriate sample size of a statistically powered trial comparing the performance of two different blood control peripheral intravenous…
- Trial name
- RIGHT IV (NCT01792778)
- Testing
- ViaValve Safety IV Catheter, Insyte Autoguard BC [Blood Control] Shielded IV Catheter
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Smiths Medical, ASD, Inc.
Jaw Edentulous
4 mm Implants in Fixed Cross-Arch Prostheses
This study aims to compare the clinical performance of 4 mm short implants supporting cross-arch fixed reconstructions in the edentulous mandible either with a combination of two short implants as distal support and two implants…
- Trial name
- NCT02877433
- Testing
- Roxolid short implant, 4 mm length (4), Roxolid short implant, 4 mm length (2)
- Where
- 2 sites in Switzerland, United Kingdom
- Volunteers
- 53 people
- Sponsor
- Institut Straumann AG
Rheumatoid Arthritis, Osteoarthritis
A Multi-centre Study to Assess the Long-term Performance of the DePuy PROXIMA™ Hip in Primary Total Hip Replacement
The purpose of this study is to monitor the performance of the DePuy PROXIMA™ hip in the treatment of patients with hip joint disease requiring a total hip replacement.
- Conditions
- Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis, Avascular Necrosis
- Trial name
- NCT00208455
- Testing
- DePuy Proxima™ Hip
- Where
- 4 sites in Germany, Italy and 2 more
- Volunteers
- 184 people
- Sponsor
- DePuy International
Staphylococcus Aureus
Evaluation of a Diagnostic Device for Detection of Nasal Staphylococcus Aureus
To establish the clinical test performance characteristics of sensitivity, specificity and predictive values for direct detection of nasal Staphylococcus aureus colonization against clinical microbiology laboratory culture…
- Trial name
- NCT00406549
- Where
- 11 sites in United States, France and 2 more
- Volunteers
- 2,000 people
- Sponsor
- Solventum US LLC
Hearing Loss, Bilateral or Unilateral
Performance of a Hearing Aid Platform Including Different Styles of Hearing Aids
The reason for this study is to evaluate a new hearing aid product generation replacing the one on the market. The goal is to evaluate the audiological performance, usability as well as features and functions.
- Trial name
- NCT02298452
- Testing
- Hearing aid.
- Where
- Switzerland
- Volunteers
- 253 people
- Sponsor
- Phonak AG, Switzerland
Instability, Joint
Safety and Performance of the SUTUREFIX ULTRA and SUTUREFIX CURVED Suture Anchors in Shoulder and Hip Arthroscopic Repair
The scientific justification is to fulfill post-market clinical requirements in order to support re-certification of the CE-Mark for this marketed product and to look into safety and efficacy.
- Trial name
- NCT03691298
- Testing
- SUTUREFIX ULTRA Suture Anchor and SUTUREFIX CURVED Suture Anchor
- Where
- 9 sites in United States, Denmark and 4 more
- Volunteers
- 83 people
- Sponsor
- Smith & Nephew Orthopaedics AG
Breast Implant Revision, Breast Augmentation Complications
Scaffold-guided Breast Implant Revision and Primary Breast Augmentation Surgery
The objective of the clinical investigation is to demonstrate safety and clinical performance of the absorbable polycaprolactone (PCL) breast scaffold combined with autologous fat grafting (AFG) for primary breast augmentation…
- Conditions
- Breast Implant Revision, Breast Augmentation Complications, Primary Breast Augmentation Surgery
- Trial name
- NCT07367698
- Testing
- Implantation of the PCL Breast scaffold with autologous fat grafting
- Where
- 3 sites in Australia
- Volunteers
- 87 people
- Sponsor
- BellaSeno Pty Ltd
Methicillin Resistance
BacLite Rapid MRSA Clinical Performance
The purpose of this study is to compare the performance of the 3M(TM) BacLite (TM) Rapid MRSA test system to traditional culture methods in detecting the presence of Methicillin Resistant Staphylococcus aureus (MRSA) directly…
- Trial name
- NCT00541632
- Where
- 9 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Solventum US LLC
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