Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05079867
Other study ID # 5906
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT04696835 - fNIRS in Pediatric Hearing Aids N/A
Completed NCT03662256 - Reducing Childhood Hearing Loss in Rural Alaska Through a Preschool Screening and Referral Process Using Mobile Health and Telemedicine N/A
Completed NCT04602780 - Evaluating the Revised WORQ in CI Users
Completed NCT03723161 - Evaluation of the Ponto Bone Anchored Hearing System in a Pediatric Atresia Population
Completed NCT05086809 - Investigation of an Updated Bone-anchored Sound Processor N/A
Active, not recruiting NCT03548779 - North Carolina Genomic Evaluation by Next-generation Exome Sequencing, 2 N/A
Completed NCT03428841 - Audiovisual Assessment After Dural Puncture During Epidural Placement in Obstetric Patients N/A
Completed NCT04559282 - Home Test of New Sound Processor N/A
Enrolling by invitation NCT03345654 - Individually-guided Hearing Aid Fitting
Completed NCT06016335 - MRI-based Synthetic CT Images of the Head and Neck N/A
Completed NCT05165121 - Comparison of Hearing Aid Fitting Outcomes Between Self-fit and Professional Fit for MDHearing Smart Hearing Aids N/A
Recruiting NCT05533840 - Establishment and Application of a New Imaging System for Otology Based on Ultra-high Resolution CT
Terminated NCT02294812 - Effects of Cognitive Training on Speech Perception N/A
Completed NCT04622059 - AUditive Direct In-utero Observation (AUDIO): Prenatal Testing of Congenital Hypoacusis N/A
Recruiting NCT02558478 - Identification of New Genes Implicated in Rare Neurosensory Diseases by Whole Exome Sequencing N/A
Withdrawn NCT02740322 - Validating the Hum Test N/A
Completed NCT01963104 - Community-Based Kiosks for Hearing Screening and Education N/A
Completed NCT01892007 - Evaluation of Cogmed Working Memory Training for Adult Hearing Aid Users N/A
Completed NCT01857661 - The Influence of the Sound Generator Combined With Conventional Amplification for Tinnitus Control: Blind Randomized Clinical Trial N/A
Withdrawn NCT01223638 - The Prevalence of Hearing Loss Among Children With Congenital Hypothyroidism N/A