DeafnessNCT02466763
Prospective Study of Round Window Versus Cochleostomy Approach to CI Surgery
A study testing Cochlear implant surgery in people with Deafness, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deafness
- What is being tested?
- Cochlear implant surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to 12 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Prospective Randomized Controlled Double-blinded Study Comparing Cochlear Implantation Through a Round Window Versus Cochleostomy Approach
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.
Read the detailed 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.
- Conditions
- Deafness
- Being tested
- Cochlear implant surgery
- Keywords
- round window, cochlear implants, cochleostomy
- Medical subject headings
- Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cochlear implant surgeryProcedure or surgery
Surgical placement of a cochlear implant device.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Cochlear implant surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: about three months post op
Secondary outcomes (3)
Participant levels of speech perception
standard audiometry speech perception tests will be administered
Measured: Preoperatively, and at approximately 1 month, 3 months, 6 months, and 12 months postoperatively
Participant levels of word recognition scores
standard audiometry CNC word score test will be administered
Measured: Preoperatively, and at approximately 1 month, 3 months, 6 months, and 12 months postoperatively
Participant levels of sentence recognition scores
standard audiometry AZBio sentence score test will be administered
Measured: Preoperatively, and at approximately 1 month, 3 months, 6 months, and 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study startMay 2015
- Primary completion12 Mar 2019
- Study completion12 Mar 2019
Why it stopped: Not enough interest in enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeafnessStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew L. Carlson, M.D., Mayo Clinic
- Investigators
- Matthew Carlson, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02466763
- Sponsor's protocol ID
- 15-000576
- Status last verified
- Jun 2019
- First submitted
- 3 Jun 2015
- Last updated
- 26 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Double-blinded Study Comparing Cochlear Implantation Through a Round Window Versus Cochleostomy Approach
- ClinicalTrials.gov ID
- NCT02466763
- Acronym / sponsor ID
- 15-000576
- Conditions
- Deafness
- Keywords
- round window, cochlear implants, cochleostomy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough interest in enrollment
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- 12 Mar 2019 (actual)
- Study completion
- 12 Mar 2019 (actual)
- First posted
- 9 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| round window | Active comparator | Procedure: Cochlear implant surgeryHalf 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. |
| cochleostomy | Active comparator | Procedure: Cochlear implant surgeryHalf 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cochlear implant surgerySurgical placement of a cochlear implant device. | Procedure or surgery | cochleostomy, round window |
Primary outcome
Cochlear implant electrode location after surgery
Time frame: about three months post op
a standard temporal bone CT scan will be used to show the location of the electrode in the cochlea
3 secondary outcomes
Participant levels of speech perception
Time frame: Preoperatively, and at approximately 1 month, 3 months, 6 months, and 12 months postoperatively
Participant levels of word recognition scores
Time frame: Preoperatively, and at approximately 1 month, 3 months, 6 months, and 12 months postoperatively
Participant levels of sentence recognition scores
Time frame: Preoperatively, and at approximately 1 month, 3 months, 6 months, and 12 months postoperatively
Results and safety
The study was stopped early (reason given: Not enough interest in enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2019.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Carlson, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cochlear implant surgery in people with Deafness, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Not enough interest in enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cochlear implant electrode location after surgery (time frame: about three months post op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2019.