Clinical trials: Device Performance, open to volunteers
- Condition Device Performance
- Status Open to volunteers
- Funder type Industry (pharma, biotech, devices)
Degenerative Hip Joint Disease, Post-traumatic Osteoarthritis
Safety and Performance Assessment of the SYMBOL Range of Medical Devices in Patients Underlying Total Hip Arthroplasty
The purpose of this post-market clinical follow up study is to assess the safety and effectiveness of the SYMBOL range of medical devices.
- Conditions
- Degenerative Hip Joint Disease, Post-traumatic Osteoarthritis, Hip Arthritis, Femoral Neck Fractures
- Trial name
- NCT05227924
- Testing
- Total hip arthroplasty (primary or revision)
- Where
- 9 sites in France
- Volunteers
- 747 people
- Sponsor
- Dedienne Sante S.A.S.
Low Back Pain
Evaluation of the Japet.W+ Medical Device for Low Back Pain Management
The JAPET.W+ medical device is a new dynamic distraction support system. It could be considered as a new solution in the therapeutic arsenal for managing common low back pain.
- Trial name
- EXODOMICILE (NCT07195422)
- Testing
- Japet.W+, Control (Standard treatment)
- Where
- 2 sites in France
- Volunteers
- 102 people
- Sponsor
- Japet Medical Devices
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.
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
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
Arthropathy of Shoulder Region, Grossly Deficient Rotator Cuff
Comprehensive Reverse Shoulder Data Collection
This study is a multicenter, prospective, non-randomized, non-controlled clinical outcome study. The primary objective of this study is to evaluate improvement of pain score at one year for the Biomet Comprehensive Reverse…
- Conditions
- Arthropathy of Shoulder Region, Grossly Deficient Rotator Cuff, Osteoarthritis of the Shoulder, Rheumatoid Arthritis Without Humeral Metaphyseal Defects
- Trial name
- NCT03404778
- Testing
- Biomet Comprehensive Reverse Shoulder
- Where
- 4 sites in United States
- Volunteers
- 175 people
- Sponsor
- Zimmer Biomet
Reconstructive Surgical Procedures, Plastic Surgery
Leica Microsystems Sponsored Study to Collect and Confirm Clinical Data on the Performance of the GLOW800 Device When Used in Accordance With Its Intended Use.
This post-market clinical follow-up (PMCF) study aims to confirm the safety and performance of the GLOW800 surgical microscope accessory when used in conjunction with the ARveo8x surgical microscope.
- Conditions
- Reconstructive Surgical Procedures, Plastic Surgery, Vascular Surgical Procedure, Cerebrovascular Disorder
- Trial name
- IMED-GLOW800 (NCT07164040)
- Testing
- The GLOW800, a non-contact, non-invasive device, allows the surgical microscope ARveo 8 and ARveo 8X to produce excitation light and resolve fluorescence emission from the fluorescent agent ICG
- Where
- 3 sites in Portugal, Spain and 1 more
- Volunteers
- 29 people
- Sponsor
- Leica Microsystems (Schweiz) AG
Suspected Grade III and IV Gliomas Requiring Surgical Intervention, Neurosurgical Procedure
Leica Microsystems Sponsored PMCF Study to Collect and Confirm Clinical Data on the Performance of the GLOW400 Device When Used in Accordance With Its Intended Use
This post-market clinical follow-up (PMCF) study aims to confirm the safety and performance of the GLOW400 surgical microscope accessory when used in conjunction with the ARveo8x surgical microscope.
- Conditions
- Suspected Grade III and IV Gliomas Requiring Surgical Intervention, Neurosurgical Procedure, Glioma, Glioblastoma (GBM)
- Trial name
- IMED-GLOW400 (NCT07366892)
- Testing
- GLOW400 is a digital surgical microscope accessory used in fluorescent visualization of suspected grade III or IV gliomas during neurosurgery.
- Where
- 2 sites in Portugal, Switzerland
- Volunteers
- 37 people
- Sponsor
- Leica Microsystems (Schweiz) AG
Intracranial Aneurysm
Safety & Performance of the World Medica World Diverter Embolization Device
The objective of this study is to investgiate the safety and clinical performance of the World Diverter Emoblization Device for the endovascular treatment of wide-neck (neck width ≥ 4 mm or dome-to-neck ratio <2) or fusiform…
- Trial name
- NCT07339358
- Testing
- Flow diverter implantation
- Where
- Spain
- Volunteers
- 72 people
- Sponsor
- World Medica USA, LLC
Bone Augmentation
Evaluation of the Safety and Performance of the Neobone®: A Prospective Observational Study in Dental Area
This study aims to collect real-world clinical data to gather information on the performance and safety of the Neobone® when used according to its intended purpose and current clinical applications.
- Trial name
- NeoDent01 (NCT07179497)
- Where
- Portugal
- Volunteers
- 66 people
- Sponsor
- Bioceramed
Temperature Change, Body, Emergency Department Visit
Performance Study of the Thermodiag Solution for Body Temperature Measurement
The goal of this prospective, comparative, multi-centre interventional clinical investigation, is to evaluate the performance of the Thermodiag® medical device, compared with reference methods, for continuous measurement of core…
- Trial name
- ThermodiagPERF (NCT06703931)
- Testing
- Measures performed on all subjects
- Where
- 4 sites in France
- Volunteers
- 60 people
- Sponsor
- F2D Medical
NEC
Sensing Oxygen Saturations Using Abdominal NIRS With an Investigational Realtime Device (Songbird)
Preterm infants are highly vulnerable and may suffer from multiple life-threatening conditions that manifest low tissue oxygenation (StO2).
- Trial name
- (Songbird) (NCT05278247)
- Testing
- NIRS
- Volunteers
- 50 people
- Sponsor
- Carag AG
Revision of a Shoulder Prosthesis
PMCF Study on the Safety, Performance and Clinical Benefits Data of the Anatomical Shoulder Bipolar System
The study is a monocentric, retrospective and prospective, non-randomized, non-controlled and consecutive series post-market study.
- Trial name
- NCT05358574
- Where
- Germany
- Volunteers
- 40 people
- Sponsor
- Zimmer Biomet
Bone Defects, Orthopaedic Surgery (30 Minutes or Longer)
Evaluation of the Safety and Performance of the Neocement® Inject P
This study aims to collect real-world clinical data to gather information on the performance and safety of the Neocement® Inject P when used according to its intended purpose and current clinical applications.
- Trial name
- NCT06973239
- Where
- Portugal
- Volunteers
- 80 people
- Sponsor
- Bioceramed
Dermatitis, Contact, Dermatitis
Post-Marketing Clinical Follow-Up Trial to Evaluate the Performance and Safety of the Medical Device 047 TD Dermatitis Cream in Adults and Children With Atopic and Contact Dermatitis Symptoms Confirmed by Clinical Parameters
The study aims to evaluate and confirm the performance of 047 TD Dermatitis cream in the improvement of eczematous dermatitis and contact dermatitis, throughout a reduction in disease severity and symptoms.
- Conditions
- Dermatitis, Contact, Dermatitis, Dermatitis, Chronic, Dermatitis, Eczematous
- Trial name
- NCT07056569
- Testing
- 047_TD Dermatitis cream twice a day for 28 days
- Where
- 3 sites in Italy
- Volunteers
- 90 people
- Sponsor
- Biokosmes Srl
Acute Ischemic Stroke
Safety and Efficacy Evaluation of the Ceretrieve Device in the Treatment of AIS Patients
The main objective of this clinical trial is to evaluate of the safety \& efficacy of the Ceretrieve device within 24 hours post thrombectomy procedure.
- Trial name
- NCT06733246
- Testing
- Aspiration 0
- Where
- Germany
- Volunteers
- 132 people
- Sponsor
- Ceretrieve Ltd.
Spine Surgery
An Open, Parallel-group, Randomized, Medical Device Study to Assess the Usability and Performance of Surgify HaloTM in Spine Surgery Versus State-of-art (Rosen Burr)
The purpose of this research study is to: test the usability and performance of the medical device Surgify Halo ™ in spine surgery test the level of "chattering " during the use of the device test the cutting performance of…
- Trial name
- NCT06827795
- Testing
- A burr used in spine surgery
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Surgify Medical Oy
Intracranial Aneurysm, Brain Arterial Disease
Safety, Performance and Usability of BALT Medical Devices: The EVIDENCE Post Marketing Clinical Follow-up Platform
BALT has designed an electronic platform to continue collecting clinical data as part of the post-marketing clinical follow-up of its devices.
- Conditions
- Intracranial Aneurysm, Brain Arterial Disease, Acute Ischemic Stroke, Peripheral Vascular Diseases
- Trial name
- EVIDENCE (NCT04927156)
- Testing
- BALT medical devices
- Where
- 12 sites in France, Germany and 1 more
- Volunteers
- 10,000 people
- Sponsor
- Balt Extrusion
Carotid Artery Stenosis
Prospective Trial of IVL for Calcified Carotid Lesions(CREATE Trial)
Clinical Trial Summary Trial Title:** CREATE Trial: Safety and Efficacy of IVL for Carotid Calcified Lesions Sponsor:** Shanghai Bluesail Boyuan Medical Technology Co., Ltd.
- Trial name
- CREATE (NCT06936176)
- Testing
- Neurovascular Intravascular Shockwave Catheter
- Where
- China
- Volunteers
- 204 people
- Sponsor
- Shanghai Bluesail Boyuan Medical Technology Co., Ltd.
RDS of Prematurity, Preterm Birth
Pivotal Study to Assess Safety and Performance of Neola®, a Novel Lung Monitoring Device for Neonates
Pivotal study to assess safety and performance of Neola®, a novel lung monitoring device for neonates
- Conditions
- RDS of Prematurity, Preterm Birth, Lung Diseases
- Trial name
- NCT07060911
- Testing
- Lung monitoring with the Neola device
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Neola Medical Inc