Clinical trials: Electrodes
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.
Paroxysmal Atrial Fibrillation
REVOLUTION (WFCC-133) - Treatment of Paroxysmal Atrial Fibrillation
The purpose of this study is to assess the safety and effectiveness of the Circular and Crescent Mapping and Ablation catheters and the workflow of the Multi-Electrode Irrigated Pulmonary Vein Isolation System when used for the…
- Trial name
- REVOLUTION (NCT01353586)
- Testing
- nMARQ™ System
- Where
- 8 sites in Belgium, Czechia and 4 more
- Volunteers
- 186 people
- Sponsor
- Biosense Webster, Inc.
Heart Failure Acute
Cardiac Output Autonomic Stimulation Therapy for Acute Heart Failure (COAST-AHF)
A feasibility study to investigate the safety and performance of the NeuroTronik Cardiac Autonomic Nerve Stimulation (CANS) Therapy System
- Trial name
- NCT03169803
- Testing
- NeuroTronik CANS Therapy™ System
- Where
- Panama
- Volunteers
- 40 people
- Sponsor
- NeuroTronik Inc.
Paroxysmal Atrial Fibrillation
Multi-electrode Radiofrequency Balloon Catheter Use for the Isolation of the Pulmonary Veins.
This clinical investigation is a prospective, multicenter, single arm clinical evaluation utilizing the multi-electrode radiofrequency balloon catheter and the multi-electrode circular diagnostic catheter.
- Trial name
- SHINE (NCT03437733)
- Testing
- Radiofrequency Ablation
- Where
- 5 sites in Czechia, Italy and 1 more
- Volunteers
- 98 people
- Sponsor
- Biosense Webster, Inc.
Cochlear Hearing Loss, Cochlear Trauma
Using Electrocochleography During Cochlear Implantation of the Neuro Zti.
The main objective of this study is to evaluate the correspondence between eCochG and residual hearing by adding two modifications.
- Trial name
- PIC-22_eCoN (NCT04651660)
- Testing
- Neuro Cochlear Implant System
- Sponsor
- Oticon Medical
Urinary Incontinence, Urinary Incontinence, Urge
Safety and Performance of UCon Patch Electrode
UCon is a medical device for treating the symptoms of overactive bladder (OAB) and bowel dysfunction (BD). It electrically stimulates the DGN through the skin to obtain modulated behavior of the bladder/bowel musculature e.g.…
- Conditions
- Urinary Incontinence, Urinary Incontinence, Urge, Nocturia, Urinary Frequency More Than Once at Night
- Trial name
- NCT06754189
- Testing
- Time Limited stimulation
- Where
- 3 sites in Denmark
- Volunteers
- 180 people
- Sponsor
- InnoCon Medical
Term Labour
Accuracy and Reliability of Novii: Fetal Heart Rate (FHR), Maternal Heart Rate (MHR) and Uterine Contraction (UA) Compared With Doppler, Scalp Fetal Scalp Electrode (FSE), Tocodynamometer (TOCO) and Intra Uterine Pressure Catheter (IUPC)
Accuracy and Reliability of the Novii device (fetal heart rate, maternal heart rate and uterine activity) compared with Food and Drug Administration (FDA) approved techniques
- Trial name
- NCT03409146
- Testing
- Monica Novii Wireless Patch System
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- GE Healthcare
Atrial Fibrillation
Clinical Study for Workflow and Performance Evaluation of the THERMOCOOL SMARTTOUCH® SF-5D System for Treating Symptomatic Paroxysmal AF (QDOT-Micro)
The QDOT-Micro study is a prospective, multi-center, non-randomized, interventional clinical study.
- Trial name
- NCT02944968
- Testing
- THERMOCOOL SMARTTOUCH® SF-5D catheter
- Volunteers
- 51 people
- Sponsor
- Biosense Webster, Inc.
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
The purpose of this study is to assess the safety and feasibility of the investigational catheter for mapping the atrial and ventricular regions of the heart.
- Conditions
- Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Ventricular Tachycardia
- Trial name
- FEATHER (NCT07116525)
- Testing
- Paddle-Shaped, High-Density, Multi-Electrode Mapping Catheter
- Where
- 5 sites in Belgium, France and 1 more
- Volunteers
- 90 people
- Sponsor
- Biosense Webster, Inc.
Back Pain, Chronic Pain
Effectiveness of Precision Spinal Cord Stimulation With Artisan Paddle Electrode
The primary objective of this study is to evaluate the acute and chronic efficacy of spinal cord stimulation using the Precision implantable neurostimulation device with the Artisan paddle electrode in patients with Failed Back…
- Conditions
- Back Pain, Chronic Pain, Pain in Leg, Unspecified
- Trial name
- NCT00386724
- Testing
- Precision Spinal Cord Stimulation System, Artisan Surgical Lead
- Where
- 2 sites in United States
- Volunteers
- 8 people
- Sponsor
- Boston Scientific Corporation
Hearing Loss, Sensorineural
Investigating Stimulation Parameter and Electrode Mode Changes on Speech Perception in Experienced Adult Cochlear Implant Recipients
This study aims to investigate the effect of stimulation parameters and different electrode modes on speech perception in adult cochlear implant recipients.
- Trial name
- DUAL (NCT06298396)
- Testing
- Program using default MAP, Program using low-power 1 (LP1) MAP, Program using low-power 2 (LP2) MAP
- Where
- Australia
- Volunteers
- 20 people
- Sponsor
- Cochlear
Cochlear Implant
Dexamethasone Eluting Cochlear Implant: a Pivotal Study
The newly developed MED-EL Cochlear Implant Mi1250 +FLEX28 DEX (CIDEXEL) incorporates the anti-inflammatory agent dexamethasone (DEX) into the electrode array.
- Trial name
- CDEX2 (NCT06142682)
- Testing
- Cochlear Implant
- Where
- 7 sites in Germany
- Volunteers
- 59 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Epilepsy, Focal Epilepsy
Assessment of Patients With Drug-resistant Temporal Lobe Epilepsy With EEG Extended With Intra-auricular Electrodes
The study aims to evaluate the effectiveness of long-term video EEG monitoring using 10-20 electrodes extended with intra-auricular electrodes in locating the seizure onset zone and interictal epileptiform discharges (IEDs) in…
- Conditions
- Epilepsy, Focal Epilepsy, Drug Resistant Epilepsy
- Trial name
- NCT06366009
- Testing
- NaoX in-ear EEG system
- Where
- Poland
- Volunteers
- 30 people
- Sponsor
- Przemyslaw Kunert
Adhesion of the Neutral Electrode 21pad
Verify the Performance of the Neutral Electrode (NE) Adhesives
The purpose of this research study is to determine the neutral electrode 21pad adhesion to the skin in accordance with international standard IEC 60601-2-2 section 201.15.101.7.
- Trial name
- NCT05376787
- Testing
- Medline NE Grounding Pad
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Medline Industries
Sternum Closure
STEELEX® Sternum Set + BONE WAX® + STEELEX® Electrode Set in Patients Undergoing Cardiac Surgery
The aim of the study is to assess the effectiveness and performance of using STEELEX® Sternum Set, BONE WAX® and STEELEX® Electrode Set in patients undergoing cardiac surgery.
- Trial name
- STEADY (NCT06065800)
- Testing
- STEELEX® Sternum Set
- Where
- Spain
- Volunteers
- 150 people
- Sponsor
- Aesculap AG
Atrial Fibrillation
Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation
The primary objective of this clinical investigation is to demonstrate safety and effectiveness of the Multi-Electrode RF Balloon catheter for the treatment of drug refractory symptomatic paroxysmal atrial fibrillation.
- Trial name
- STELLAR (NCT03683030)
- Testing
- Multi-Electrode RF Balloon Catheter
- Where
- 41 sites in United States, China and 1 more
- Volunteers
- 397 people
- Sponsor
- Biosense Webster, Inc.
Transforaminal Lumbar Interbody Fusion Surgery
The Objective of the Protocol is to Generate Real World Evidence (RWE) Supporting the Safety, Performance, and Health Economics of Using the Regulatory Approved and Commercially Available EARP Interbody System Used During Lumbar Interbody Fusion (LIF) Procedures With the EARP Nerve Cuff Electrode
The goal of the trial is to generate data to support the safety, performance, and cost effectiveness of using the EARP devices during Lumbar Interbody Fusion (LIF) procedures.
- Trial name
- EARP-2 (NCT07020000)
- Testing
- Device: Nerve Cuff and Retractor System
- Where
- 5 sites in United States
- Volunteers
- 120 people
- Sponsor
- Retropsoas Technologies, LLC
Thyroid Nodule, Thyroid Goiter
Prospective Evaluation of the Pulse Biosciences nPulse™ Vybrance™ Percutaneous Electrode System
The primary objective of this study is to reproduce in a multi-center study results obtained during the feasibility First-In-Human (FIH) study with Prof.
- Conditions
- Thyroid Nodule, Thyroid Goiter, Ablation
- Trial name
- PRECISE-BTN (NCT07287176)
- Testing
- nPulse Vybrance Percutaneous Electrode System
- Where
- 3 sites in United States
- Volunteers
- 103 people
- Sponsor
- Pulse Biosciences, Inc.
Healthy
Wearable Garment vs Gel Electrodes for Electrical Muscle Stimulation
The goal of this study is to evaluate whether textile-based electrodes can provide neurostimulation that is comparable in comfort and effectiveness to traditional hydrogel electrodes in healthy adults.
- Trial name
- NCT07050784
- Testing
- Hydrogel electrodes, Dry polymer-textile electrodes with Skin Lotion A, Dry textile electrodes with gel pads attached to the electrode
- Where
- Canada
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Myant Medical Corp.
Facial Paralysis, Bell Palsy
Artificial Eye Blinking Stimulation Following Paralysis of the Facial Nerve
Artificial eye blinking stimulation following damage to the facial nerve. Group 1 - Patients with a persistent unilateral facial paralysis (palsy) that underwent an operation for facial reanimation Group 2 - Patients with…
- Trial name
- Bioniceye (NCT04153916)
- Testing
- Neurotrigger eye blinking stimulator
- Where
- Israel
- Volunteers
- 20 people
- Sponsor
- Neurotrigger Ltd