Clinical trials: Electrodes, Implanted
Sensorineural Hearing Loss, Bilateral Hearing Loss
Long-term Follow-up of a Cochlear Implant With Dexamethasone Eluting Electrode Array
A long-term follow-up of Cochlear's cochlear implant electrode array which passively elutes dexamethasone for a defined period of time to help reduce inflammatory responses.
- Trial name
- CI-DEX-LTFU (NCT06936449)
- Testing
- CI632D, CI632
- Where
- 3 sites in United States
- Volunteers
- 19 people
- Sponsor
- Cochlear
Heart Failure, Ventricular Dysfunction
Safety and Performance of Electrodes Implanted in the Left Ventricle
The study is intended to demonstrate the safe implant of small receiver-electrodes into the endocardial surface of the left ventricle and to demonstrate its utility in providing cardiac resynchronization therapy in heart failure…
- Conditions
- Heart Failure, Ventricular Dysfunction, Cardiomyopathies, Heart Diseases
- Trial name
- SELECT-LV (NCT01905670)
- Testing
- WiCS-LV system
- Where
- 2 sites in Czechia, Denmark
- Volunteers
- 39 people
- Sponsor
- EBR Systems, Inc.
Hearing Loss, Bilateral Sensorineural, Hearing Loss, Sensorineural
Performance and Hearing-related Outcomes in Adults Implanted With the CI622D Dexamethasone-eluting Cochlear Implant Compared to Those Implanted With a Standard Cochlear Implant (CI622)
This clinical study will test a newly developed cochlear implant known as CI622D. This experimental cochlear implant has been designed to slowly release a drug called dexamethasone.
- Conditions
- Hearing Loss, Bilateral Sensorineural, Hearing Loss, Sensorineural, Hearing Loss, Bilateral, Hearing Loss, Cochlear
- Trial name
- DETECT (NCT06424262)
- Testing
- CI622D, CI622
- Where
- 11 sites in Australia, France and 2 more
- Volunteers
- 50 people
- Sponsor
- Cochlear
Sensorineural Hearing Loss, Bilateral Hearing Loss
Cochlear Implant With Dexamethasone Eluting Electrode Array
An evaluation of Cochlear's cochlear implant electrode array which passively elutes dexamethasone for a defined period of time to help reduce inflammatory responses.
- Trial name
- NCT04750642
- Testing
- CI632D, CI632
- Where
- 8 sites in United States, Australia and 1 more
- Volunteers
- 42 people
- Sponsor
- Cochlear
Hearing Loss, Partial Deafness
Implantation of the HiRes90K™ Advantage Cochlear Implant With HiFocus™ Mid-Scala and Development of a Combined Electric and Acoustic Stimulation Technology in Adults With Partial Deafness
The purpose of this feasibility study is to evaluate whether low-frequency acoustic hearing sensitivity can be preserved in newly implanted adults with partial deafness (considerable low frequency acoustic hearing profiles with…
- Conditions
- Hearing Loss, Partial Deafness, Hearing Disorders, Ear Diseases
- Trial name
- NCT02189798
- Testing
- HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode, EAS sound processor
- Where
- 11 sites in United States
- Volunteers
- 67 people
- Sponsor
- Advanced Bionics
Congestive Heart Failure
Clinical Study of the EASYTRAK 3 Spiral Fixation Coronary Venous Bipolar Pace/Sense Lead
The purpose of this clinical investigation was to assess the safety and effectiveness of the EASYTRAK 3 lead
- Trial name
- NCT00158938
- Testing
- EASYTRAK 3 left ventricular pacing lead
- Volunteers
- 115 people
- Sponsor
- Boston Scientific Corporation
Hearing Loss
Safety and Efficacy of a Drug Eluting Slim Modiolar Electrode Array
This clinical study will test a new type of cochlear implant known as CI632D. This experimental cochlear implant has been designed to slowly release a drug called dexamethasone.
- Trial name
- DEE-REX (NCT06598059)
- Testing
- Cochlear implant, Dexamethasone
- Where
- 11 sites in United States
- Volunteers
- 56 people
- Sponsor
- Cochlear
Cochlear Implants
Longitudinal Outcomes in MED-EL Cochlear Implant Recipients Using a FLEX Electrode
This retrospective study aims at analysing data from clinical routine as anonymized data sets. The study aims at analysing clinical data from MED-EL Cochlear Implant (CI) recipients using a FLEX electrode array.
- Trial name
- LOTOS (NCT06343571)
- Where
- Germany
- Volunteers
- 2,000 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Hearing Loss, Ear Diseases
Benefits of the HiResolution Bionic Ear System in Adults With Asymmetric Hearing Loss
The purpose of this feasibility study is to evaluate the benefit of unilateral implantation in adults who have severe to profound sensorineural hearing loss in one ear, and up to moderate sensorineural hearing loss in the other…
- Conditions
- Hearing Loss, Ear Diseases, Hearing Disorders, Otorhinolaryngologic Diseases
- Trial name
- NCT02811549
- Testing
- HiResolution Bionic Cochlear Implant
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Advanced Bionics
Cochlear Implant
Hearing Preservation and Electro-acoustic Stimulation With EVO® Electrode Lead and Zebra® Sound Processor
Some candidates to cochlear implantation can have residual low frequencies hearing. The EVO electrode lead has been specifically designed to preserve this residual hearing through surgery.
- Trial name
- NCT02966379
- Testing
- cochlear implantation
- Where
- 8 sites in France
- Volunteers
- 17 people
- Sponsor
- Oticon Medical
Ventricular Fibrillation, Ventricular Tachycardia
Further Acute Research of a Subcutaneous Implantable Defibrillator (S-ICD) System
The purpose is to further evaluate the operation, safety, and feasibility of a subcutaneous implantable defibrillator (S-ICD) system in patients who require an implantable cardioverter defibrillator (ICD)for treating ventricular…
- Trial name
- NCT00399217
- Testing
- Subcutaneous Implantable Defibrillator (S-ICD) system, ICD
- Where
- United Kingdom
- Volunteers
- 55 people
- Sponsor
- Boston Scientific Corporation
Bradycardia
SITELINE 2 Polyurethane
The SITELINE 2 Polyurethane Clinical Investigation analyzed the safety and electrical performance of the SITELINE 2 Polyurethane pacing lead.
- Trial name
- NCT00180284
- Testing
- SITELINE 2 Polyurethane (pacing lead)
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Boston Scientific Corporation
Hearing Loss, Sensorineural, Sensorineural Hearing Loss
Dexamethasone-Eluting Cochlear Implant Electrode
A newly developed MED-EL Cochlear Implant incorporates the anti-inflammatory agent dexamethasone (DEX) into the electrode array.
- Trial name
- CIDEX (NCT04450290)
- Testing
- CIDEXEL implant
- Where
- Germany
- Volunteers
- 10 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Sensorineural Hearing Loss, Bilateral
Study of a Minimally Invasive Cochlear Access for Cochlear Implantation Via a Robotic Procedure
The objectives of this study are to explore the efficacy and safety of a robotic procedure for a minimally invasive cochlear implantation.
- Trial name
- NCT04777565
- Testing
- Robotic surgery
- Where
- France
- Volunteers
- 10 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Bradycardia, Congestive Heart Failure
The EASYTRAK EPI Clinical Investigation
The purpose of this study is to assess the safety and effectiveness of the EASYTRAK EPI lead.
- Trial name
- EASYTRAK EPI (NCT00158925)
- Testing
- EASYTRAK EPI lead
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Boston Scientific Corporation
Cochlear Implantation, Monitoring Electrode Insertion
Evaluating a New Software (OTOGUIDE) to Help Monitor Electrode Insertion During Cochlear Implant Surgery.
Cochlear implants are a successful treatment for severe hearing loss in both children and adults. The procedure involves placing an electrode array into the cochlea to stimulate the auditory nerve, helping patients to hear.
- Trial name
- OGUID (NCT07690995)
- Testing
- OTOGUIDE software
- Where
- 2 sites in Austria, Germany
- Volunteers
- 42 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Hearing Loss
Multi-center Study to Examine Changes to the Environment Surrounding the Electrodes in the Cochlea and to Capture the Most Challenging Listening Environments Experienced by Persons With a Cochlear Implant
This early feasibility study aims to collect pilot data on impedance measurements in real-world environments and to collect real-world and difficult listening situations and the factors impacting this, reflecting situations the…
- Trial name
- DICE (NCT06173687)
- Testing
- The impedance measurement task using the Mobile Research App (MRA)
- Where
- 4 sites in Australia, Belgium and 1 more
- Volunteers
- 51 people
- Sponsor
- Cochlear
Hearing Loss, Deafness
Evaluation of Hearing Preservation in Adults With Partial Low-Frequency Hearing Implanted With the HiFocus™ Mid-Scala Electrode
The purpose of this study is to determine the feasibility of preserving low-frequency acoustic hearing in adults with a moderate degree of hearing loss in the low frequencies and severe-to-profound hearing loss in the mid-to-high…
- Conditions
- Hearing Loss, Deafness, Hearing Disorders, Ear Diseases
- Trial name
- NCT01959152
- Testing
- HiRes™ 90K Advantage implant with HiFocus™ Mid-Scala electrode
- Where
- 3 sites in Canada
- Volunteers
- 1 people
- Sponsor
- Advanced Bionics
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
Depressive Disorder, Major
European Deep Brain Stimulation (DBS) Depression Study
To evaluate the effects of two different programming settings of deep brain stimulation (DBS) in the subgenual white matter (Brodmann Area 25 WM) as an adjunctive treatment for treatment resistant Major Depressive Disorder…
- Trial name
- NCT01331330
- Testing
- Deep Brain Stimulation
- Where
- 5 sites in France, Israel and 1 more
- Volunteers
- 9 people
- Sponsor
- Abbott Medical Devices