Prospective Study of Round Window Versus Cochleostomy Approach to CI

Status Terminated

Clinical Trial Summary

To the investigators' knowledge, no clinical study has prospectively investigated the relationship between surgical insertion technique, intracochlear electrode location, and postoperative hearing outcomes. To this end, the investigators are conducting a multicenter prospective randomized controlled double-blinded study comparing round window and cochleostomy cochlear implant electrode insertion.

Clinical Trial Description

Cochlear implant procedure has become the standard of care for patients with severe-to-profound sensorineural hearing loss. Successful outcomes are dependent on extrinsic and intrinsic factors. Significant predictive factors for hearing outcomes in patients with CIs have been previously reported. These include, but are not limited to, duration of deafness, level of preimplant speech recognition, pre/postlingual status, and the coupling of device electrodes. Recipient age does not appear to have a significant impact on hearing outcomes in elderly candidates.

A number of recent studies have proposed that intraoperative factors may be important determinants of electrode location and possibly of audiological outcome. Preliminary reports suggest that intracochlear electrode position- specifically, placement within the ST-is associated with improved audiological outcomes. Additionally, different surgical techniques have been proposed to minimize trauma during electrode insertion and to increase the likelihood of placement within the ST - namely round window and anteroinferior cochleostomy electrode insertion.

Currently, the best surgical approach for electrode insertion is highly debated, fueled by a lack of strong evidence to support one method over another. While a number of CI centers have begun to utilize a round window approach, many large volume centers in the United States and world wide continue to routinely employ cochleostomy electrode insertions. With an increasing number of patients being implanted with greater degrees of residual hearing, such data will become critical towards reducing intracochlear injury and optimizing patient outcomes. To the investigators' knowledge, no clinical study has prospectively investigated the relationship between surgical insertion technique, intracochlear electrode location, and postoperative hearing outcomes. To this end, the investigators are initiating a multicenter prospective randomized controlled double-blinded study comparing round window and cochleostomy cochlear implant electrode insertion. ;

Study Design

Related Conditions & MeSH terms

Deafness

Clinical Trial Details

NCT number	NCT02466763
Study type	Interventional
Source	Mayo Clinic
Contact
Status	Terminated
Phase	N/A
Start date	May 2015
Completion date	March 12, 2019

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05086809` - Investigation of an Updated Bone-anchored Sound Processor	N/A
Withdrawn	`NCT02890576` - Ambulatory Telemonitoring of People With Hearing Loss and Having a Cochlear Implant COCHLESURV
Completed	`NCT01256229` - Outcomes In Children With Developmental Delay And Deafness	Phase 1
Recruiting	`NCT04795986` - First Clinical Evaluation of HEARO Robotic Cochlear Implantation Surgery in Austria
Recruiting	`NCT05867173` - Perceptual Consequences of Cochlear Implant Electrode-neuron Interfaces	N/A
Completed	`NCT06104813` - Evaluation of Deaf Men's Knowledge About Sexual Health
Completed	`NCT04563884` - Validity of the French Version of Deafness Questionnaires for Children and Adolescents
Not yet recruiting	`NCT06088953` - EARLY DETECTION OF DEAFNESS IN A MEMORY CENTER	N/A
Completed	`NCT03980808` - American Sign Language-Accessible Diabetes Education	N/A
Completed	`NCT03694340` - Optimization of Cochlear Implant MAP-parameters in Children	N/A
Terminated	`NCT01959152` - Evaluation of Hearing Preservation in Adults With Partial Low-Frequency Hearing Implanted With the HiFocus™ Mid-Scala Electrode	N/A
Completed	`NCT02539901` - Development of a Deaf Child With a Cochlear Implant.	N/A
Withdrawn	`NCT00604474` - Development of Auditory Skills in Young Deaf Children With Bilateral Cochlear Implants	N/A
Completed	`NCT00511381` - Genetic Testing in Detection of Late-Onset Hearing Loss	N/A
Terminated	`NCT03867058` - Tradeoff Between Spatial and Temporal Resolution
Completed	`NCT01109576` - Workshops for Veterans With Vision and Hearing Loss	Phase 0
Completed	`NCT01400178` - Cochlear Implants in Post-lingually Children: Results After 10 Years	N/A
Completed	`NCT04106063` - A New Speech, Spatial, and Qualities of Hearing Scale Short-Form for Deaf Children
Active, not recruiting	`NCT03352154` - Long Latency Auditory Evoked Potentials (P300) Outcomes in Patients With Unilateral Cochlear Implants	N/A
Recruiting	`NCT04495660` - Restauration of the Auditory and Cognitive Functions in Cochlear Implanted Deaf Children in fNIRS	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Prospective Study of Round Window Versus Cochleostomy Approach to CI Surgery

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms