Robotic and Manual Cochlear Implantation: An Intra-individual Study of Speech Recognition and Electrode Holder Position (ICRobMan) - Trial NCT06235073
Access comprehensive clinical trial information for NCT06235073 through Pure Global AI's free database. This phase not specified trial is sponsored by University Hospital, Brest and is currently Completed. The study focuses on Cochlear Hearing Loss. Target enrollment is 10 participants.
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Study Focus
Observational
Sponsor & Location
University Hospital, Brest
Timeline & Enrollment
N/A
Jul 01, 2023
Sep 30, 2023
Primary Outcome
Speech disyllabic recognition
Summary
Cochlear implantation (CI) allows rehabilitation for patients with severe to profound hearing
 impairment. Although the use of a robotic assistant provides technical assistance to the
 surgeon, the assessment of the impact of its use on auditory outcomes remains uncertain, due
 to inter-individual variability of preoperative audiometric thresholds and the various
 possible intrascalar positions of the electrode array. WThe investigators aim to compare the
 hearing results of patients who underwent bilateral cochlear implantation, one side was
 performed with manual insertion and the other side with robot-assisted insertion. The
 electrode array intrascalar positioning and the surgery duration were also studied.
 
 This retrospective intra-individual study involved 10 patients who underwent bilateral
 cochlear implantation. The unique composition of this cohort enabled the investigators to
 utilize each patient as their own control.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06235073
Non-Device Trial