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Cochlear Trauma, Functional and Structural Preservation in Cochlear Implant Surgery

NCT ID: NCT05079867

Last Updated: 2021-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-19

Study Completion Date

2023-12-19

Brief Summary

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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

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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)

Conditions

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Hearing Loss Cochlear Implant Cochlear Microphonics Electrocochleography

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Perimodiolar (PM)

Patients to be implanted with: Mid Scala or CI532 / 632 (Slim modiolar) electrode

Cochlear implantation

Intervention Type DEVICE

Electrode surgically implanted in patient's cochlea to improve hearing

Lateral wall (PL)

Patients to be implanted with: Slim J or CI522 / 622 (Slim Lateral) electrode

Cochlear implantation

Intervention Type DEVICE

Electrode surgically implanted in patient's cochlea to improve hearing

Interventions

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Cochlear implantation

Electrode surgically implanted in patient's cochlea to improve hearing

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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.
Minimum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Italiano de Buenos Aires

OTHER

Sponsor Role lead

Responsible Party

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FEDERICO ALBERTO DI LELLA

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Federico A Di Lella, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Italiano de Buenos Aires

Locations

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Hospital Italiano de Buenos Aires

Capital Federal, Buenos Aires, Argentina

Site Status RECRUITING

Countries

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Argentina

Central Contacts

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Federico A Di Lella, MD PhD

Role: CONTACT

[email protected]
+5411 49590200 ext. 9490

Facility Contacts

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Federico A Di Lella, MD PhD

Role: primary

[email protected]
54-11-49590200 ext. 9490

Other Identifiers

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5906

Identifier Type: -

Identifier Source: org_study_id