Cochlear ImplantsNCT03807830
Exploring the Use of ECochG Testing During Electrode Insertion in Cochlear Implant Surgery
A study testing Electrocochlography in people with Cochlear Implants and Hearing Preservation, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Investigation of a new ECoChG system (Electrocochleography) during the surgical insertion of cochlear implants, for patients with Advanced Bionics devices. The sound recordings created may be useful in aiding the surgeon to better implant the patient by letting him or her know if they are damaging the ear during… Read more about this study
- Who is it for?
- Ages 12 months and olderHealthy volunteers can take part
- Conditions the study is for
- Cochlear Implants, Hearing Preservation
- What is being tested?
- Electrocochlography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Jan 2019to 1 Sep 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 12 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients between ages of 12 months to 6 years old, and Adults over 18 years old
- Meets normal candidacy requirements for cochlear implantation
- Advanced Bionics (AB) implant has been selected for patient at MDT
- Patient has capacity to consent
- Patent cochlea as verified by CT or MRI scan
- No cochlear abnormality that might prevent insertion of the electrode array
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- Measurable residual hearing in the ear to be implanted
- No additional handicap that would prevent study procedures being followed
- Agreement to participate in the study
Who cannot join
- Complex cases where minimal duration of surgery is required. Although ECochG adds less than 10 minutes to the surgery time.
- Patients lacking the capacity to consent
Trial locations and contacts
1 site in 1 country.
About this study
Investigation of a new ECoChG system (Electrocochleography) during the surgical insertion of cochlear implants, for patients with Advanced Bionics devices.
The sound recordings created may be useful in aiding the surgeon to better implant the patient by letting him or her know if they are damaging the ear during implantation in real time
Patients will be followed up for 1 year post surgery within our trial, and have a further 3 ECochGs performed in the clinic setting, (6 weeks, 6 months, 1 year) through their implants.
Read the detailed description
Cochlear implant candidature has changed in the past years. Today many cochlear implant recipients have some low frequency residual hearing in the ear which is to be implanted. To help preserve hearing, the electrode array must be inserted extremely carefully. It is desirable to have real-time feedback relating to progress of the electrode insertion.
One possible tool that might provide this is an electrocochleography (ECochG). A brief low-frequency acoustic tone at a fixed level is delivered to the external ear canal. This results in normal movements of the outer and the inner hair cells inside the inner ear. These movements are known to produce small electrical potentials that have been previously been sensed by a recording electrode placed on the promontory, or surface of the bone in which the cochlea is located. Averaging of these recordings in synchrony with the acoustic stimulus allows the small ECochG signal to be reinforced while any physiological or electrical noise is averaged out. With ECochG measurements different aspects of the auditory system can be tested. For the investigators work only the cochlear microphonic, generated by the outer hair cells will be recorded and analysed.
The Advanced Bionics (AB) implant system is uniquely suited to do such measurements. The aim of the study is to monitor electrode array insertion during surgery and any residual hearing function over time in using this tool as a comparison to conventional methods. Subjects will undergo the study procedure of ECochG measurements, alongside additional standard of care appointments for the research, pure tone audiometry and impedence measurement. Only a 10 minute ECochG measurement will be the additional research component to the patients clinical routine as mentioned above.
- Conditions
- Cochlear Implants, Hearing Preservation
- Being tested
- Electrocochlography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectrocochlographyProcedure or surgery
Intra-operative ECochG recording via the implant, post operative ECochG measurements. Impedances measured over time.
| Study group | Role | What they receive |
|---|---|---|
| One arm feasbility study | Other | Not described Receives: Procedure: Electrocochlography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure cochlear micro phonic amplitude
To measure objectively the cochlear micro phonic amplitude either intra or post operatively within initial 12 months of cochlear implant use
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start11 Jan 2019
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear ImplantsStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cambridge
- Responsible party
- Principal investigator, Sophie Newton, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Manohar L Bance, MD, Principal investigator, The Emmeline Centre for Cochlear Implants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807830
- Sponsor's protocol ID
- 18/EE/0304
- Status last verified
- Nov 2019
- First submitted
- 11 Jan 2019
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Use of ECochG Testing During Electrode Insertion in Cochlear Implant Surgery
- ClinicalTrials.gov ID
- NCT03807830
- Acronym / sponsor ID
- 18/EE/0304
- Conditions
- Cochlear Implants, Hearing Preservation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Cambridge
- Study start
- 11 Jan 2019 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 17 Jan 2019 (actual)
- 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.
Investigation of a new ECoChG system (Electrocochleography) during the surgical insertion of cochlear implants, for patients with Advanced Bionics devices.
The sound recordings created may be useful in aiding the surgeon to better implant the patient by letting him or her know if they are damaging the ear during implantation in real time
Patients will be followed up for 1 year post surgery within our trial, and have a further 3 ECochGs performed in the clinic setting, (6 weeks, 6 months, 1 year) through their implants.
Detailed description
Cochlear implant candidature has changed in the past years. Today many cochlear implant recipients have some low frequency residual hearing in the ear which is to be implanted. To help preserve hearing, the electrode array must be inserted extremely carefully. It is desirable to have real-time feedback relating to progress of the electrode insertion.
One possible tool that might provide this is an electrocochleography (ECochG). A brief low-frequency acoustic tone at a fixed level is delivered to the external ear canal. This results in normal movements of the outer and the inner hair cells inside the inner ear. These movements are known to produce small electrical potentials that have been previously been sensed by a recording electrode placed on the promontory, or surface of the bone in which the cochlea is located. Averaging of these recordings in synchrony with the acoustic stimulus allows the small ECochG signal to be reinforced while any physiological or electrical noise is averaged out. With ECochG measurements different aspects of the auditory system can be tested. For the investigators work only the cochlear microphonic, generated by the outer hair cells will be recorded and analysed.
The Advanced Bionics (AB) implant system is uniquely suited to do such measurements. The aim of the study is to monitor electrode array insertion during surgery and any residual hearing function over time in using this tool as a comparison to conventional methods. Subjects will undergo the study procedure of ECochG measurements, alongside additional standard of care appointments for the research, pure tone audiometry and impedence measurement. Only a 10 minute ECochG measurement will be the additional research component to the patients clinical routine as mentioned above.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One arm feasbility study | Other | Procedure: Electrocochlography |
Who may qualify
- Ages
- 12 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Patients between ages of 12 months to 6 years old, and Adults over 18 years old
- Meets normal candidacy requirements for cochlear implantation
- Advanced Bionics (AB) implant has been selected for patient at MDT
- Patient has capacity to consent
- Patent cochlea as verified by CT or MRI scan
Key exclusion criteria (2 listed)
- Complex cases where minimal duration of surgery is required. Although ECochG adds less than 10 minutes to the surgery time.
- Patients lacking the capacity to consent
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 |
|---|---|---|
| ElectrocochlographyIntra-operative ECochG recording via the implant, post operative ECochG measurements. Impedances measured over time. | Procedure or surgery | One arm feasbility study |
Primary outcome
Measure cochlear micro phonic amplitude
Time frame: 12 months
To measure objectively the cochlear micro phonic amplitude either intra or post operatively within initial 12 months of cochlear implant use
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
- Individual participant dataSharing planned: Undecided
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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.
Manohar L Bance, MD principal investigator
The Emmeline Centre for Cochlear Implants
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrocochlography in people with Cochlear Implants and Hearing Preservation, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 9 inclusion and 2 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: finished, as of the sponsor's last update on 26 Nov 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 Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measure cochlear micro phonic amplitude (time frame: 12 months). 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 Nov 2019.