Cochlear Trauma, Functional and Structural Preservation in Cochlear Implant Surgery

NCT05079867 | Unknown

• 1 other identifier: 5906
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hearing Loss; Cochlear Implant; Cochlear Microphonics; Electrocochleography

Outcome Measures

Primary Outcomes (1)

• Amplitude of cochlear microphonics

  Postoperative amplitude of cochlear microphonics

  0-12 months

Secondary Outcomes (2)

• Cochlear implant impedance

  0-12 months

• Residual hearing

  0-12 months

Study Arms (2)

Perimodiolar (PM)

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

Device: Cochlear implantation

Lateral wall (PL)

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

Device: Cochlear implantation

Interventions

Cochlear implantation DEVICE

Electrode surgically implanted in patient's cochlea to improve hearing

Lateral wall (PL); Perimodiolar (PM)

Eligibility Criteria

• Age: 12 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients over 12 months of age who will receive a cochlear implant

You may qualify if:

• 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

You may not qualify if:

• Medical or pharmacological comorbid condition that contraindicates cochlear implantation.
• Surgical impossibility to follow the guidelines of the minimally traumatic technique.

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead

Study Sites (1)

Hospital Italiano de Buenos Aires

Capital Federal, Buenos Aires, C1199ABB, Argentina

RECRUITING

MeSH Terms

Conditions

Hearing Loss

Interventions

Cochlear Implantation

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Otologic Surgical Procedures; Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation

Study Officials

• Federico A Di Lella, MD PhD

  Hospital Italiano de Buenos Aires

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Federico A Di Lella, MD PhD

CONTACT

+5411 49590200; federico.dilella@hospitalitaliano.org.ar

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: October 3, 2021
• First Posted: October 15, 2021
• Study Start: July 19, 2021
• Primary Completion: December 19, 2022
• Study Completion: December 19, 2023
• Last Updated: October 15, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)