Cochlear Trauma, Functional and Structural Preservation in Cochlear Implant Surgery

Hearing Loss Clinical Trial

Official title:

Cochlear Trauma, Functional and Structural Preservation in Cochlear Implant Surgery: Comparative Study Between Perimodiolar and Lateral Wall Electrodes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05079867
• Other study ID #: 5906
• Status: Recruiting
• Start date: July 19, 2021
• Est. completion date: December 19, 2023

Study information

• Verified date: October 2021
• Source: Hospital Italiano de Buenos Aires
• Contact: Federico A Di Lella, MD PhD
• Phone: +5411 49590200
• Email: federico.dilella[@]hospitalitaliano.org.ar
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 19, 2023
• Est. primary completion date: December 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months and older

Eligibility

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.

Related Conditions & MeSH terms

• Cochlear Implant
• Hearing Loss

Intervention

Device:
• Cochlear implantation
Electrode surgically implanted in patient's cochlea to improve hearing

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires	Capital federal	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Italiano de Buenos Aires

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amplitude of cochlear microphonics	Postoperative amplitude of cochlear microphonics	0-12 months
Secondary	Cochlear implant impedance	Postoperative value of cochlear implant impedance	0-12 months
Secondary	Residual hearing	Average audiometric threshold	0-12 months