Prospective Study of Round Window Versus Cochleostomy Approach to CI Surgery

Deafness Clinical Trial

Official title:

Prospective Randomized Controlled Double-blinded Study Comparing Cochlear Implantation Through a Round Window Versus Cochleostomy Approach

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02466763
• Other study ID #: 15-000576
• Status: Terminated
• Phase: N/A
• Start date: May 2015
• Est. completion date: March 12, 2019

Study information

• Verified date: June 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: March 12, 2019
• Est. primary completion date: March 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria are:

• 18 years of age or older,

• less than a 10-year duration of deafness in the ear to be implanted,

• primary surgery,

• normal shaped cochleae,

• no retrocochlear pathology, and

• grossly normal cognitive function.

Exclusion criteria are:

• less than 18 years of age,

• prelingual deafness, or

• greater than 10-years duration of deafness in the ear to be implanted;

• prior otologic surgery in the implanted ear (excluding tympanostomy tube placement),

• inner ear malformation present in the ear to be implanted,

• retrocochlear pathology present in the auditory system to be implanted,

• developmental delay or known cognitive impairment, or

• pregnancy.

Related Conditions & MeSH terms

• Deafness

Intervention

Procedure:
• Cochlear implant surgery
Surgical placement of a cochlear implant device.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cochlear implant electrode location after surgery	a standard temporal bone CT scan will be used to show the location of the electrode in the cochlea	about three months post op
Secondary	Participant levels of speech perception	standard audiometry speech perception tests will be administered	Preoperatively, and at approximately 1 month, 3 months, 6 months, and 12 months postoperatively
Secondary	Participant levels of word recognition scores	standard audiometry CNC word score test will be administered	Preoperatively, and at approximately 1 month, 3 months, 6 months, and 12 months postoperatively
Secondary	Participant levels of sentence recognition scores	standard audiometry AZBio sentence score test will be administered	Preoperatively, and at approximately 1 month, 3 months, 6 months, and 12 months postoperatively

External Links

•   Mayo Clinic Clinical Trials