Clinical trials: Device Performance, open to volunteers
Stroke
Mirror Therapy Rehabilitation of the Upper Limb After Stroke (NEURO-MIROIR 2)
Hemiparesis is a common motor disorder after a stroke. The majority of patients do not recover functional use of their paretic upper limb.
- Trial name
- NEUROMIROIR2 (NCT04119544)
- Testing
- Conventional rehabilitation, Intensive Visual Simulation
- Where
- 5 sites in France
- Volunteers
- 66 people
- Sponsor
- Clinique Les Trois Soleils
Parkinson Disease (PD)
Use Of A Tongue Strength Training Device And Its Relationship With Speech In Patients With Parkinson's Disease
Parkinson's Disease affects the brain and causes several movement problems. These problems include stiff muscles, slow movements, shaking when resting, and trouble keeping balance.
- Trial name
- IOPI (NCT06921122)
- Testing
- IOWA ORAL PERFORMANCE INSTRUMENT
- Where
- Brazil
- Volunteers
- 60 people
- Sponsor
- Hospital de Clinicas de Porto Alegre
Amputees
Evaluation of a Multimodal Tactile Feedback System for Upper Limb-loss Users: Embodiment and Performance
The aim of this study is to evaluate the effect of integrating tactile feedback systems into a robotic upper-limb prosthesis. These systems deliver pressure stimuli (through small silicone chambers that inflate), vibration…
- Trial name
- THE_FBHAND (NCT07418645)
- Testing
- Pressure and vibrotactile feedbak, Pressure feedback, Vibrotactile feedback
- Where
- Italy
- Volunteers
- 9 people
- Sponsor
- University of Pisa
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
Orotracheal Intubation
AI-Integrated 3D-Printed Videolaryngoscope for Orotracheal Intubation in Critically Ill Patients
Background: Orotracheal intubation is an essential procedure in critically ill patients requiring ventilatory support, and the use of videolaryngoscopy is recommended as the gold standard in clinical practice.
- Trial name
- VL-AI (NCT07592702)
- Testing
- Orotracheal intubation using a 3D videolaryngoscope integrated with artificial intelligence (VL-IA)., Commercially available gold-standard videolaryngoscope (VL-C)
- Where
- 4 sites in Brazil
- Volunteers
- 120 people
- Sponsor
- Federal University of Pelotas
Aesthetic Improvement of the Skin, Skin Hydration in Healthy Volunteers
Clinical Investigation on a Polynucleotide-based Device Used to Improve Skin Hydration
Adequate skin hydration is critical for maintaining healthy skin. Moreover, dehydration, together with reduction in cell renewal, loss of radiance, elasticity and firmness, is involved in skin aging.
- Conditions
- Aesthetic Improvement of the Skin, Skin Hydration in Healthy Volunteers, Skin Elasticity, Skin Turgor
- Trial name
- NCT07151859
- Testing
- PN30 (RDM16)
- Where
- Italy
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Mastelli S.r.l
Cardiac Surgery, Heart Surgery
Safety and Performance Evaluation of CPB Venous and Arterial Cannulas
This is a two-phase study evaluating the Eurosets arterial and venous cannulas for use during cardiopulmonary bypass (CPB) procedures. Phase 1 is a pilot study focused on assessing cannula safety.
- Conditions
- Cardiac Surgery, Heart Surgery, Cardiopulmonary Bypass, Coronary Surgery
- Trial name
- NCT07354841
- Testing
- Eurosets Venous and Arterial Cannula, Control Arterial and Venous Cannulas
- Where
- Italy
- Volunteers
- 80 people
- Sponsor
- Eurosets S.r.l.
Sepsis, Device Performance
PIVO Use for Blood Cultures in the Emergency Department
The investigators will implement a protocol for use of the PIVO device for blood culture collection in the emergency department.
- Conditions
- Sepsis, Device Performance, Emergency Medicine
- Trial name
- PIVO-ED (NCT07348289)
- Testing
- PIVO device, a needle-free blood draw device
- Where
- United States
- Volunteers
- 10,000 people
- Sponsor
- Intermountain Health Care, Inc.
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.
Neurological Disorders, Health Adult Subjects
Device for Driving Simulation for the Rehabilitation of Balance and Proprioception
The DriveSim clinical trial investigates a dynamic driving simulator designed to train and assess functional motor and cognitive skills in individuals with neurological disorders.
- Trial name
- DRIVESIM (NCT07539272)
- Testing
- DriveSim Rehab, Conventional Rehabilitation
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University of Pavia
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
Atrial Fibrillation
Safety and Performance of ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device
The study is designed to evaluate the safety and performance of the ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device in Patients with non-valvular Atrial Fibrillation, who are at increased risk for stroke, and that…
- Trial name
- NCT06099106
- Testing
- SEPIOLA System
- Where
- 5 sites in Georgia, Lithuania and 2 more
- Volunteers
- 15 people
- Sponsor
- Endomatic Ltd.
Pregnant Women
Performance and Safety of Assisted Vaginal Delivery With the Odon Device™ Versus Vacuum Extraction
This is a pivotal study designed to demonstrate the non-inferiority of the Odon Device™ versus vacuum extraction
- Trial name
- E-SAFE-ODON (NCT07862842)
- Testing
- Experimental: The BD Odon DeviceTM, Active Comparator: Vacuum extraction group
- Volunteers
- 628 people
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Coronary Artery Disease, Ischemic Heart Disease
LONG NAGOMI™ PMCF STUDY
The study is designed as a prospective, multi-center, observational PMCF (post-market clinical follow-up) study of the Ultimaster Nagomi™ _stent (lengths of 38, 44 and 50 mm) in the treatment of coronary artery disease according…
- Trial name
- LONG NAGOMI (NCT07399002)
- Testing
- LONG NAGOMI
- Where
- 10 sites in Spain
- Volunteers
- 1,039 people
- Sponsor
- Fundación EPIC
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
Cataract
Assessment of Visual Function and Optics in Intraocular Lenses
The main objective of this research is to assess visual function and optical performance of CE marked, implanted intraocular lenses to understand the individual factors that affect their performance and how these may be improved…
- Trial name
- NCT01654159
- Testing
- Monofocal IOL, Multifocal IOL, Toric IOL
- Where
- United Kingdom
- Volunteers
- 500 people
- Sponsor
- Aston University
Onychomycosis of Toenail
URGO MICKAEL Filmogel, Topical Treatment of Onychomycosis
The objective of this clinical study is to evaluate the performance of URGO MICKAEL Filmogel as a topical treatment for mild to moderate onychomycosis
- Trial name
- MICKAEL (NCT07828184)
- Testing
- URGO MICKAEL Filmogel
- Where
- France
- Volunteers
- 54 people
- Sponsor
- CEN Biotech
Rhegmatogenous Retinal Detachment - Macula Off
Acute Retinal Detachment Repair With the iSeelr™ Retinal Detachment Repair System
This study is a first-in-human clinical trial testing a new treatment for rhegmatogenous retinal detachments. The new treatment called retinal thermofusion uses a special laser device called iSeelr™ during surgery.
- Trial name
- NCT06468397
- Testing
- iSeelr™
- Where
- Australia
- Volunteers
- 10 people
- Sponsor
- Photofuse Pty Ltd
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
Hip Osteoarthritis, Rheumatoid Arthritis
G7 Dual Mobility With Vivacit-E or Longevity PMCF
This study is a global, multi-center, prospective, non-controlled, non-randomized, post-market clinical follow-up study. The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of…
- Conditions
- Hip Osteoarthritis, Rheumatoid Arthritis, Joint Diseases, Avascular Necrosis
- Trial name
- NCT05548972
- Testing
- G7 Dual Mobility with Vivacit-E bearing, G7 Dual Mobility Longevity bearing
- Where
- 10 sites in United States, Belgium and 2 more
- Volunteers
- 358 people
- Sponsor
- Zimmer Biomet