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

NCT06235073 · University Hospital, Brest · Updated 31 Jan 2024

What is being tested
Not stated
For
Cochlear Hearing Loss
Kind of study
Watches patients without assigning a treatment. No drug phase (a device or procedure study).
Who can join
Ages 44 years to 73 years. About 10 people. The full rules are on the registry page.
Where
France
When
Starts or started 1 July 2023, ends 30 Sept 2023. Registered 31 Jan 2024.
Results
None posted yet.

In the researchers' words

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.
ClinicalTrials.gov, NCT06235073

Sites

  • Chru de BrestBrest, France