Trial record 6 of 1382 for:    "Mayo Clinic" [Exact]

Prospective Study of Round Window Versus Cochleostomy Approach to CI Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Matthew L. Carlson, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02466763
First received: June 3, 2015
Last updated: June 8, 2015
Last verified: June 2015
  Purpose

In 1985, the United States Food and Drug Administration (FDA) approved multichannel cochlear implants (CIs) for adults with profound hearing loss; and in 1990, implantation was approved for children. Since then, this procedure has become the standard of care for patients with severe-to-profound sensorineural hearing loss. Successful outcomes are dependent not only on extrinsic factors, but also on intrinsic factors that cannot always be modified by the CI team. 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.

Earlier studies have found that, because of its dimensions and proximity to the spiral ganglion cells, the scala tympani (ST) is the preferred location for CI electrode placement. 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.


Condition Intervention
Deafness
Procedure: Cochlear implant surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Prospective Randomized Controlled Double-blinded Study Comparing Cochlear Implantation Through a Round Window Versus Cochleostomy Approach

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Cochlear implant electrode location after surgery [ Time Frame: about three months post op ] [ Designated as safety issue: No ]
    a standard temporal bone CT scan will be used to show the location of the electrode in the cochlea


Secondary Outcome Measures:
  • Participant levels of speech perception [ Time Frame: Preoperatively, and at approximately 1 month, 3 months, 6 months, and 12 months postoperatively ] [ Designated as safety issue: No ]
    standard audiometry speech perception tests will be administered

  • Participant levels of word recognition scores [ Time Frame: Preoperatively, and at approximately 1 month, 3 months, 6 months, and 12 months postoperatively ] [ Designated as safety issue: No ]
    standard audiometry CNC word score test will be administered

  • Participant levels of sentence recognition scores [ Time Frame: Preoperatively, and at approximately 1 month, 3 months, 6 months, and 12 months postoperatively ] [ Designated as safety issue: No ]
    standard audiometry AZBio sentence score test will be administered


Estimated Enrollment: 100
Study Start Date: May 2015
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: round window
Half of the participants will be randomized to the round window technique of cochlear implant device electrode insertion. Intervention for participants randomized to the round window arm include having the round window technique used for the electrode insertion during the participant's cochlear implant surgery. Participants in this arm of the study will also have a post operative CT scan at about three months after surgery.
Procedure: Cochlear implant surgery
Surgical placement of a cochlear implant device.
Active Comparator: cochleostomy
Half of the participants will be randomized to the cochleostomy technique of cochlear implant device electrode insertion. For the participants randomized to the cochleostomy arm, the surgeon will use a cochleostomy technique for the electrode insertion during the participant's cochlear implant surgery. Participants in this arm of the study will also have a post operative CT scan at about three months after surgery.
Procedure: Cochlear implant surgery
Surgical placement of a cochlear implant device.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02466763

Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Nicole M Tombers, BS, RN    507-538-1392 ext 2    tombers.nicole@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Matthew Carlson, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Matthew L. Carlson, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02466763     History of Changes
Other Study ID Numbers: 15-000576
Study First Received: June 3, 2015
Last Updated: June 8, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
round window
cochlear implants
cochleostomy

ClinicalTrials.gov processed this record on July 01, 2015