Clinical trials: Device Performance
Melanoma (Skin Cancer)
Investigation of the Performance of the Medical Device Dermalyser in Determining Melanoma Thickness Based on Dermoscopy Images
In Sweden, approximately 9,000 Swedes are affected by melanoma annually, and each year, 500 individuals die from metastatic melanoma. The prognosis for melanoma primarily depends on the thickness of the tumor at diagnosis.
- Trial name
- AI-DSII (NCT06788665)
- Testing
- Medical Device Dermalyser
- Where
- Sweden
- Volunteers
- 900 people
- Sponsor
- Vastra Gotaland Region
Atrial Fibrillation
Safety and Performance of a Pulsed Field Device for Global Mapping and Ablation of the Left Atrium for the Treatment of Atrial Fibrillation
The purpose of this study is to provide clinical data pertaining to the safety and performance of the Globe Mapping and Pulsed Field Ablation System for treating subjects with atrial fibrillation (AF).
- Trial name
- PULSE-EU (NCT05164107)
- Testing
- Globe Mapping and Pulsed Field Ablation System (Globe PF System)
- Where
- Czechia
- Volunteers
- 175 people
- Sponsor
- Kardium Inc.
Dyslexia
Evaluation of the Performance and Safety of a Medical Device Developed to Improve the Reading of Dyslexic Patients
The aim of this study is to evaluate the efficacy and safety of a new medical device on the improvement of reading skills of dyslexic patients.
- Trial name
- DysLight (NCT04157829)
- Testing
- Scintilling lamp, Classic lamp
- Where
- 4 sites in France
- Volunteers
- 33 people
- Sponsor
- SATT Ouest Valorisation
Prostate Cancer
Performance Evaluation of the AMS CONTINUUM™ Device
1. To assess the safety of using the CONTINUUM™ device by monitoring the side effects and complications associated with the Device following a radical prostatectomy. 2.
- Trial name
- NCT00894933
- Testing
- CONTINUUM™
- Where
- 6 sites in United States
- Volunteers
- 33 people
- Sponsor
- American Medical Systems
Healthy Adults, Gait Analysis
Validity and Reliability of Gait and Jump Parameters Measured by the iSen Device in Healthy Adults
This study aims to evaluate the validity and reliability of gait and jumping parameters measured with the iSen device in healthy adults.
- Conditions
- Healthy Adults, Gait Analysis, Jumping Performance, Reliability and Validity
- Trial name
- NCT06994793
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Kırıkkale University
Rheumatoid Arthritis
The SetPoint System Safety & Performance Post-Approval Study
Prospective, multicenter, post-market, registry study designed to systematically collect real-world data (RWD) from participants implanted with the SetPoint System [implanted, vagus-mediated, neuroimmune modulator] for the…
- Trial name
- ACTIVATE (NCT07489326)
- Testing
- SetPoint System
- Volunteers
- 150 people
- Sponsor
- SetPoint Medical Corporation
Polyp, Colorectal
Colorectal Polyp Clinical Decision Support Device Study
The study objective is to establish the efficacy of the colorectal polyp Clinical Decision Support Device (CDSD) in clinical use.
- Conditions
- Polyp, Colorectal, Colonoscopy
- Trial name
- CDSD (NCT04437615)
- Testing
- Colonoscopy, Clinical Decision Support Device
- Where
- United States
- Volunteers
- 2,379 people
- Sponsor
- Olympus Corporation of the Americas
Total Knee Arthroplasty
Comparison of Intraoperative Warming Devices
The sublingual (under the tongue) core temperature within 10 minutes of arrival in the post anesthesia care unit (PACU) for patients warmed with the Dynatherm vitalHeat2 (VH2) System under general anesthesia for total knee…
- Trial name
- NCT00711867
- Testing
- VH2, Bair Hugger
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- Mayo Clinic
Cervical Cytology, PAP
Techcyte SureView Cervical Cytology System Clinical Validation Study
The clinical study is a multi-center, retrospective, blinded, matched-pair, two-arm clinical study in which one test assessment and a control assessment of liquid-based cytology (LBC) pap tests are performed and compared to a…
- Trial name
- NCT06767111
- Testing
- Digital cervical cytology slide imaging system with artificial intelligence (AI) algorithm in vitro diagnostic (IVD) device
- Where
- United States
- Volunteers
- 4,596 people, healthy volunteers welcome
- Sponsor
- Techcyte, Inc.
Task Performance
Electrosurgery Wars;Ligasure or Enseal in Total Laparoscopic Hysterectomy
The effect of two different bipolar instruments were compared in terms of operative time, total operative time, intra-operative blood loss and intra-operative and postoperative complications.
- Trial name
- NCT03433209
- Testing
- Ligasure device, Articulating Enseal
- Volunteers
- 134 people
- Sponsor
- Antalya Training and Research Hospital
Degenerative Disc Disease, Degenerative Spondylolisthesis
Lumbar Interbody Implant Study
The objective of this study is to evaluate the safety and performance of NuVasive interbody implants when used during thoracic and/or lumbar spine surgery as measured by reported complications, radiographic outcomes, and…
- Conditions
- Degenerative Disc Disease, Degenerative Spondylolisthesis, Degenerative Scoliosis, Spinal Stenosis
- Trial name
- NCT04418830
- Where
- 16 sites in United States
- Volunteers
- 1,050 people
- Sponsor
- NuVasive
Visual Acuity
Evaluation of a Digital Visual Acuity Device vs. Standard Visual Acuity Measurements
The purpose of this research is to validate and determine the accuracy of the experimental device when measuring visual acuity versus our standard visual acuity measurements and to gather voice recordings of letters to help build…
- Trial name
- NCT06431295
- Testing
- FaceScan
- Where
- United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Diabetic Retinopathy
A Multi-center Study to Evaluate Performance of an Automated Device for the Detection of Diabetic Retinopathy
Diabetes affects 30.3 million people or 9.3% of the population of the United States. Results of a study by the Eye Diseases Prevalence Research Group reveal that 40% of diabetes patients have some degree of diabetic retinopathy…
- Trial name
- NCT02963441
- Testing
- LumineticsCore (formerly IDX-DR)
- Volunteers
- 900 people
- Sponsor
- Digital Diagnostics, Inc.
Peripheral Arterial Disease
Exoskeleton Footwear to Improve Walking
The purpose of this study is to determine the best assistance level of an exoskeleton footwear (EF) that can assist walking for people older than 40 with and without peripheral artery disease (PAD).
- Trial name
- NCT04337554
- Testing
- Exoskeleton footwear
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- VA Office of Research and Development
Contact Lens Complication, Astigmatism
T30 for Astigmatism in Digital Device Users
This study aims to determine if Total30 lenses for astigmatism can be successfully fit in participants who are heavy digital device users.
- Conditions
- Contact Lens Complication, Astigmatism, Refractive Errors
- Trial name
- T30FA (NCT06266728)
- Testing
- Total30 for Astigmatism Contact Lenses
- Where
- 2 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Southern College of Optometry
Thoracic Diseases
Observational Registry Characterizing the CTAG Device With ACTIVE CONTROL
Collect real-world clinical and device-specific outcomes of the GORE® TAG® Conformable Thoracic Stent Graft featuring ACTIVE CONTROL System (CTAG Device with ACTIVE CONTROL) in the treatment of aortic disease as part of routine…
- Trial name
- SURPASS (NCT03286400)
- Testing
- CTAG Device with ACTIVE CONTROL
- Where
- 20 sites in France, Germany and 5 more
- Volunteers
- 127 people
- Sponsor
- W.L.Gore & Associates
Mitral Regurgitation
Treatment of Mitral Regurgitation Using a Minimally Invasive Approach With the HARPOON Device.
To evaluate the long-term safety and performance of the HARPOON™ MVRS for use in patients presenting with severe degenerative mitral regurgitation due to posterior leaflet prolapse in the post-market phase.
- Trial name
- ASCEND (NCT04382612)
- Testing
- HARPOON Beating Heart Mitral Valve Repair System (MVRS)
- Where
- 10 sites in Austria, Germany and 2 more
- Volunteers
- 42 people
- Sponsor
- Edwards Lifesciences
Refractive Errors, Accomodation
Study in Pediatric Volunteers of a Handheld Device Versus a Standard Diagnostic Device in Ophthalmic Refraction
This study is exploratory and examines whether the refraction results obtained from a novel optical device yields results similar to the ophthalmic refraction measurements obtained from an autorefractor in children.
- Conditions
- Refractive Errors, Accomodation, Diagnostic Self Evaluation
- Trial name
- NCT04955379
- Testing
- EQ103
- Where
- Israel
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- EyeQue Corp.
Sleep-Disordered Breathing
Comparative Assessment of Compumedics Somfit Sleep Monitoring Device
To study whether Somfit is substantially equivalent to the existing approved devices for full polysomnography and home sleep apnea testing
- Trial name
- NCT05647746
- Testing
- Compumedics Somfit HSAT device, WatchPAT HSAT device, Compumedics Grael /E-series PSG system
- Where
- Australia
- Volunteers
- 108 people
- Sponsor
- Compumedics Limited
Rheumatoid Arthritis With Adequate Bone Quality, Inflammatory Arthritis
PMCF Study on the Safety and Performance of the Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty
This study is a multicenter, prospective, non-controlled post market clinical follow-up study. The objectives of this study are to confirm the safety and performance of the commercially available Zimmer® Maxera™ Acetabular System…
- Conditions
- Rheumatoid Arthritis With Adequate Bone Quality, Inflammatory Arthritis, Osteoarthritis, Hip, Avascular Necrosis
- Trial name
- NCT03372278
- Where
- 8 sites in Australia, Belgium and 6 more
- Volunteers
- 250 people
- Sponsor
- Zimmer Biomet