Hearing LossNCT05079867
Cochlear Trauma, Functional and Structural Preservation in Cochlear Implant Surgery
An observational study of Hearing Loss and Cochlear Implant, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial summary
Prospective 2-arm cohort consisting of a preoperative visit and visits at the time of implantation (Day 0) and follow-up in patients for whom their treating physician indicated a perimodiolar or straight cochlear implant. Read more about this study
- Who is it for?
- Ages 12 months and older
- Conditions the study is for
- Hearing Loss, Cochlear Implant, Cochlear Microphonics
- What is being tested?
- Cochlear implantation
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteArgentina
- Study dates
- 19 Jul 2021to 19 Dec 2023
- Phase
- Observational
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients over 12 months of age who will receive a cochlear implant
Who may be able to join
- Patients to receive a Cochlear implant 12 Months of age or older at the time of incorporation Willingness to participate and comply with the requirements of the protocol Residual hearing better than 80 dBA at 500 Hz
Who cannot join
- Medical or pharmacological comorbid condition that contraindicates cochlear implantation.
- Previous implantation in the ear of the new implant Ossification or any other cochlear abnormality that could prevent the complete insertion of the electrode guide Abnormal cochlear / neural anatomy on preoperative CT or MRI (excluding dilated vestibular aqueduct syndrome) Deafness due to lesions of the central auditory pathway. (Exclusion for evaluation of residual hearing) Diagnosis of Auditory Neuropathy Spectrum Disorder (Exclusion for evaluation of residual hearing) Active infection in the middle ear Chronic inflammatory processes in the middle ear Disabilities that could prevent participation in the evaluations Unrealistic expectations on the part of the participant regarding the possible benefits, risks and limitations inherent to the procedure or research protocol.
- Surgical impossibility to follow the guidelines of the minimally traumatic technique.
Trial locations and contacts
1 site in 1 country.
Argentina1 site, 1 recruiting
- Recruiting
Hospital Italiano de Buenos Aires
Capital Federal, Buenos Aires, C1199ABB
Federico A Di Lella, MD PhD, 54-11-49590200 ext. 9490, federico.dilella@hospitalitaliano.org.ar
About this study
Official title: Cochlear Trauma, Functional and Structural Preservation in Cochlear Implant Surgery: Comparative Study Between Perimodiolar and Lateral Wall Electrodes
Prospective 2-arm cohort consisting of a preoperative visit and visits at the time of implantation (Day 0) and follow-up in patients for whom their treating physician indicated a perimodiolar or straight cochlear implant.
Read the detailed description
Branches:
- Perimodiolar (PM)
- Lateral wall (PL)
Follow up schedule:
Preoperative visit POV1 (up to 90 days before D0) Intraoperative visit D0 (Surgery - Day 0) Follow-up visit 1 FUV1 (48 hours) Follow-up visit 2 FUV2 14 days Follow-up visit 3 FUV3 (4 weeks) Follow-up visit 4 FUV4 (3 months) Follow-up visit 5 FUV5 (6 months) Follow-up visit 6 FUV6 (12 months)
- Being tested
- Cochlear implantation
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cochlear implantationDevice
Electrode surgically implanted in patient's cochlea to improve hearing
| Study group | Role | What they receive |
|---|---|---|
| Perimodiolar (PM) | Patients to be implanted with: Mid Scala or CI532 / 632 (Slim modiolar) electrode Receives: Device: Cochlear implantation | |
| Lateral wall (PL) | Patients to be implanted with: Slim J or CI522 / 622 (Slim Lateral) electrode Receives: Device: Cochlear implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amplitude of cochlear microphonics
Postoperative amplitude of cochlear microphonics
Measured: 0-12 months
Secondary outcomes (2)
Cochlear implant impedance
Postoperative value of cochlear implant impedance
Measured: 0-12 months
Residual hearing
Average audiometric threshold
Measured: 0-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start19 Jul 2021
- Primary completion19 Dec 2022 (estimated)
- Study completion19 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FEDERICO ALBERTO DI LELLA, Hospital Italiano de Buenos Aires
- Investigators
- Federico A Di Lella, MD PhD, Principal investigator, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05079867
- Sponsor's protocol ID
- 5906
- Status last verified
- Oct 2021
- First submitted
- 3 Oct 2021
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cochlear Trauma, Functional and Structural Preservation in Cochlear Implant Surgery: Comparative Study Between Perimodiolar and Lateral Wall Electrodes
- ClinicalTrials.gov ID
- NCT05079867
- Acronym / sponsor ID
- 5906
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- 19 Jul 2021 (actual)
- Primary completion
- 19 Dec 2022 (estimated)
- Study completion
- 19 Dec 2023 (estimated)
- First posted
- 15 Oct 2021 (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.
Prospective 2-arm cohort consisting of a preoperative visit and visits at the time of implantation (Day 0) and follow-up in patients for whom their treating physician indicated a perimodiolar or straight cochlear implant.
Detailed description
Branches:
- Perimodiolar (PM)
- Lateral wall (PL)
Follow up schedule:
Preoperative visit POV1 (up to 90 days before D0) Intraoperative visit D0 (Surgery - Day 0) Follow-up visit 1 FUV1 (48 hours) Follow-up visit 2 FUV2 14 days Follow-up visit 3 FUV3 (4 weeks) Follow-up visit 4 FUV4 (3 months) Follow-up visit 5 FUV5 (6 months) Follow-up visit 6 FUV6 (12 months)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perimodiolar (PM) | – | Device: Cochlear implantationPatients to be implanted with: Mid Scala or CI532 / 632 (Slim modiolar) electrode |
| Lateral wall (PL) | – | Device: Cochlear implantationPatients to be implanted with: Slim J or CI522 / 622 (Slim Lateral) electrode |
Who may qualify
- Ages
- 12 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients over 12 months of age who will receive a cochlear implant
Key inclusion criteria (1 listed)
- Patients to receive a Cochlear implant 12 Months of age or older at the time of incorporation Willingness to participate and comply with the requirements of the protocol Residual hearing better than 80 dBA at 500 Hz
Key exclusion criteria (3 listed)
- Medical or pharmacological comorbid condition that contraindicates cochlear implantation.
- Previous implantation in the ear of the new implant Ossification or any other cochlear abnormality that could prevent the complete insertion of the electrode guide Abnormal cochlear / neural anatomy on preoperative CT or MRI (excluding dilated vestibular aqueduct syndrome) Deafness due to lesions of the central auditory pathway. (Exclusion for evaluation of residual hearing) Diagnosis of Auditory Neuropathy Spectrum Disorder (Exclusion for evaluation of residual hearing) Active infection in the middle ear Chronic inflammatory processes in the middle ear Disabilities that could prevent participation in the evaluations Unrealistic expectations on the part of the participant regarding the possible benefits, risks and limitations inherent to the procedure or research protocol.
- Surgical impossibility to follow the guidelines of the minimally traumatic technique.
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 implantationElectrode surgically implanted in patient's cochlea to improve hearing | Device | Lateral wall (PL), Perimodiolar (PM) |
Primary outcome
Amplitude of cochlear microphonics
Time frame: 0-12 months
Postoperative amplitude of cochlear microphonics
2 secondary outcomes
Cochlear implant impedance
Time frame: 0-12 months
Residual hearing
Time frame: 0-12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Individual participant dataSharing planned: No. There is no plan to share IPD to other researchers.
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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.
Federico A Di Lella, MD PhD principal investigator
Hospital Italiano de Buenos Aires
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss and Cochlear Implant, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 15 Oct 2021. 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 Argentina. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Federico A Di Lella, MD PhD (+5411 49590200 ext. 9490, federico.dilella@hospitalitaliano.org.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amplitude of cochlear microphonics (time frame: 0-12 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 15 Oct 2021.