NCT02466763

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 3, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 9, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2019

Completed
Last Updated

June 26, 2019

Status Verified

June 1, 2019

Enrollment Period

3.9 years

First QC Date

June 3, 2015

Last Update Submit

June 24, 2019

Conditions

Deafness

Keywords

round windowcochlear implantscochleostomy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Participant levels of speech perception

    Preoperatively, and at approximately 1 month, 3 months, 6 months, and 12 months postoperatively

  • Participant levels of word recognition scores

    Preoperatively, and at approximately 1 month, 3 months, 6 months, and 12 months postoperatively

  • Participant levels of sentence recognition scores

    Preoperatively, and at approximately 1 month, 3 months, 6 months, and 12 months postoperatively

Study Arms (2)

round window

ACTIVE COMPARATOR

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

cochleostomy

ACTIVE COMPARATOR

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

Interventions

Cochlear implant surgeryPROCEDURE

Surgical placement of a cochlear implant device.

cochleostomyround window

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Deafness

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Matthew Carlson, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

June 3, 2015

First Posted

June 9, 2015

Study Start

May 1, 2015

Primary Completion

March 12, 2019

Study Completion

March 12, 2019

Last Updated

June 26, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)