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NCT06235073

Robotic and Manual Cochlear Implantation: An Intra-individual Study of Speech Recognition and Electrode Holder Position (ICRobMan)

Robotic and Manual Cochlear Implantation: An Intra-individual Study of Speech Recognition and Electrode Holder Position
University Hospital, Brest·ClinicalTrials.govCompleted
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Study focus
Disease/Condition
Cochlear Hearing Loss
Study type
Observational
Sponsor & location
Primary sponsor
University Hospital, Brest
Location
Brest, France
Timeline & enrollment
Phase
N/A
Start date
Jul 01, 2023
End date
Sep 30, 2023
Enrollment
10 participants
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
Other hearing lossOther specified hearing lossOtotoxic hearing lossHearing loss, unspecifiedSudden idiopathic hearing loss
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06235073
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.