Clinical trials: Cochlear Implant Surgery
Tympanostomy Tube Insertion
Prediciton of the Round Window Visibility Through Posterior Tympanotomy by CT Scan Analysis
It is difficult to predict the intraoperative visibility of the round window through the posterior Tympanostomy. In case of non-visualization, the surgeon may have to change operative technique during cochlear implant surgery.
- Trial name
- NCT03589209
- Where
- France
- Volunteers
- 100 people
- Sponsor
- University Hospital, Strasbourg, France
Sensorineural Hearing Loss, Cochlear Implant
Cochlear Electrical Impedance and the Effect of Topical Dexamethasone on Cochlear Implant Surgery
Hearing is the ability to perceive sounds through the ear. If the transmission of sound is defective, the person suffers some degree of hearing loss.
- Trial name
- NCT03374514
- Testing
- Dexamethasone, Sterile isotonic saline solution
- Where
- Argentina
- Volunteers
- 20 people
- Sponsor
- Hospital Italiano de Buenos Aires
Severe to Profound Sensorineural Hearing Loss, Undergoing Cochlear Implant Surgery
Radiological Classification of the Facial Nerve
Cortical mastoidectomy and posterior tympanotomy is a classic approach for cochlear implant. Intimate knowledge of the relevant surgical anatomy of the temporal bone and facial recess is important to safely perform the posterior…
- Trial name
- NCT02925208
- Testing
- cochlear implant surgery
- Where
- Saudi Arabia
- Volunteers
- 140 people
- Sponsor
- Imam Abdulrahman Bin Faisal University
Hearing Loss, Cochlear, Cochlear Implantation
Post-Market Clinical Investigation of the IotaSOFT Insertion System
The purpose of the proposed study is to evaluate the continued safety of the iotaSOFT Insertion System when used by a surgeon to assist with inserting a CI electrode array in one ear per subject
- Conditions
- Hearing Loss, Cochlear, Cochlear Implantation, Hearing Loss, Sensorineural
- Trial name
- ACE (NCT06664697)
- Testing
- Cochlear Implantation with Robotic-Assisted Insertion System
- Where
- 3 sites in United States
- Volunteers
- 50 people
- Sponsor
- iotaMotion, Inc.
CHARGE Syndrome
A Strategic Approach to Safe and Effective Cochlear Implantation in Patients With CHARGE Syndrome
This retrospective observational study aims to evaluate cochlear anatomy, surgical challenges, and strategic approaches for safe cochlear implantation in pediatric patients with CHARGE syndrome.
- Trial name
- NCT07320482
- Testing
- No intervention (observational study)
- Where
- South Korea
- Volunteers
- 12 people
- Sponsor
- Seoul National University Bundang Hospital
Cochlear Implants, Hearing Preservation
Exploring the Use of ECochG Testing During Electrode Insertion in Cochlear Implant Surgery
Investigation of a new ECoChG system (Electrocochleography) during the surgical insertion of cochlear implants, for patients with Advanced Bionics devices.
- Trial name
- NCT03807830
- Testing
- Electrocochlography
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Cambridge University Hospitals NHS Foundation Trust
Anesthesia
Role of LIDOCAINE IN Pediatric Cochlear Implant Surgery
The stapedius reflex protects the ear from the loud noise. The measurement of the intraoperative electrically evoked stapedial reflex threshold (ESRT) during pediatric cochlear implants (CIs) is used to confirm that the implant…
- Trial name
- NCT04194294
- Testing
- Lidocaine, Na CL 0.9%
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Wahba bakhet
Hearing Loss, Sensorineural, Hearing Loss, Bilateral
iotaSOFT Pediatric Study
Prospective, non-randomized, open-label study to evaluate the safety and efficacy of the iotaSOFT Insertion System when used to assist electrode array insertion during cochlear implant surgery in a pediatric population.
- Conditions
- Hearing Loss, Sensorineural, Hearing Loss, Bilateral, Hearing Loss, Unilateral
- Trial name
- NCT06106373
- Testing
- iotaSOFT Insertion System
- Where
- 2 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- iotaMotion, Inc.
Otolaryngological Diseases Requiring Mastoidectomy, Middle Ear Surgery, Endolymphatic Sac Surgery, Cochlear Implant, Labyrinthectomy, Petrous Apex Lesions, Facial Nerve Surgery, and Lateral Skull Base Tumors
AI Recognition of Important Structures in Otolaryngological Surgery
Developing a system for artificial intelligence to recognize anatomical landmarks in otolaryngological surgery, enabling real-time tracking of critical temporal bone structures during surgery.
- Trial name
- NCT06726551
- Where
- China
- Volunteers
- 1,000 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sevoflurane, Propofol
Effects of Propofol and Sevoflurane on Blood Folic Acid and Homocysteine Concentrations in Children
To investigate the effect of sevoflurane and propofol on the concentrations of serum homocysteine and folic acid in children who received cochlear implant surgery.
- Conditions
- Sevoflurane, Propofol, Homocysteine, Cochlear Hearing Loss
- Trial name
- NCT03595163
- Testing
- Sevoflurane, Propofol
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Anesthesia, Local
Local Anesthesia for Pediatric Cochlear Implant
Propofol with remifentanil provides good operative conditions for pediatric cochlear implant (CI); however, large doses of remifentanil usually result in postoperative hyperalgesia and increase postoperative pain.
- Trial name
- NCT03721081
- Testing
- Lidocaine 1%/Epi 1:200000, Na Cl 0.9%/Epi 1:200000
- Where
- Egypt
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Wahba bakhet
Cochlear Implants, Evoked Potentials, Auditory
Optimization of Cochlear Implant MAP-parameters in Children
This project will complete a long-term follow up for children that have received cochlear implants (CI) early in life and had their CI's programmed based on objective measurements.
- Conditions
- Cochlear Implants, Evoked Potentials, Auditory, Child, Disabilities Hearing
- Trial name
- NCT03694340
- Testing
- Re-programming of cochlear implant
- Where
- Sweden
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Göteborg University
Tympanomastoid Surgery, Cochlear Implant
Great Auricular Nerve Block for Children Undergoing Tympanomastoid Surgery
The investigators goal is to determine the efficacy and duration of analgesia with the addition of Clonidine, an alpha-2 agonist, to local anesthetic blockade using bupivacaine, of the great auricular nerve in children undergoing…
- Conditions
- Tympanomastoid Surgery, Cochlear Implant, Mastoidectomy, Cholesteatoma
- Trial name
- NCT01638052
- Testing
- 0.25% Bupivacaine + Clonidine
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
Postoperative Infection
Post-operative Antibiotics; Effects on Risk of Infection After Cochlear Implant Surgery
Currently there is little consensus regarding postoperative antibiotic prophylactic treatment and its effect on the postoperative infection rate after Cochlear implantation.
- Trial name
- NCT06177444
- Testing
- Antibiotic
- Where
- Denmark
- Volunteers
- 920 people, healthy volunteers welcome
- Sponsor
- Odense University Hospital
Hearing Loss, Cochlear Implant
Cochlear Trauma, Functional and Structural Preservation in Cochlear Implant Surgery
Prospective 2-arm cohort consisting of a preoperative visit and visits at the time of implantation (Day 0) and follow-up in patients for whom their treating physician indicated a perimodiolar or straight cochlear implant.
- Conditions
- Hearing Loss, Cochlear Implant, Cochlear Microphonics, Electrocochleography
- Trial name
- NCT05079867
- Testing
- Cochlear implantation
- Where
- Argentina
- Volunteers
- 40 people
- Sponsor
- Hospital Italiano de Buenos Aires
Anesthesia
Role of Magnesium in Pediatric Cochlear Implant
To determine the efficiency of addition of magnesium sulfate to total intravenous anesthesia (TIVA) in optimizing the surgical field during pediatric cochlear implant surgery.
- Trial name
- NCT03722940
- Testing
- Magnesium sulphate, Na CL 0.9%
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Wahba bakhet
Hearing Loss, Sensorineural, Cochlear Implantation
Evaluation of the Automated Integration of a Robotics and ECochG System for Use With Cochlear Implant Surgery
Evaluation of the Automated Integration of a Robotics and ECochG System for Use with Cochlear Implant Surgery
- Trial name
- AIMBOT (NCT06664710)
- Testing
- iotaSOFT Insertion System with AIM, iotaSOFT Insertion System with AIM Control
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- iotaMotion, Inc.
Acoustic Neuroma, Labyrinthitis Ossificans
Maintaining Cochlear Patency After VIIIth Nerve Surgery
Tumors arising from the VIIIth Nerve (vestibulo-cochlear nerve) typically present with progressive unilateral hearing loss and tinnitus.
- Conditions
- Acoustic Neuroma, Labyrinthitis Ossificans, Profound Hearing Impairment
- Trial name
- NCT03261726
- Testing
- MedEl Test Electrode Placer
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Henry Ford Health System