Impact of Robotic Cochlear Implantation on Hearing Performance in Noise

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study is to compare two methods of cochlear implantation : conventional manual insertion versus robot-assisted in order to verify whether robotic insertion provides better performance in the noisy environment. To do this, we will compare the two methods of insertion of the electrode holder, on 140 patients candidates for cochlear implantation randomized in two groups (70 conventional surgery versus 70 robot-assisted surgery). All patients will be recruited during 17 months, in our Ear, nose and throat (ENT) Department of the Pitié-Salpêtrière hospital group, the first center for adult patients established in France (on average 180 patients/year). Patient will be followed for 9 months with clinical evaluation, imaging, audiometric, listening effort and quality of life assessments. These evaluations will be carried out preoperatively and postoperatively at 3 months and 6 months post-activation of the cochlear implant.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult patient ≥ 18 years old

• Patients with an indication for uni or bilateral, simultaneous or sequential cochlear implantation: severe to profound bilateral deafness with intelligibility ≤70% for Fournier dissyllabic words, in free field, at 60dB with adapted hearing aids.

• Patient able to understand the information note and give written consent

• Affiliation to a French social security system

Locations
Other Locations
France
Groupe Hospitalier Pitié-Salpêtrière
RECRUITING
Paris
Contact Information
Primary
Ghizlene LAHLOU, Dr
ghizlene.lahlou@aphp.fr
01 42 16 26 10
Backup
Isabelle MOSNIER, Dr
isabelle.mosnier@aphp.fr
01 42 16 26 10
Time Frame
Start Date: 2024-02-20
Estimated Completion Date: 2025-12
Participants
Target number of participants: 140
Treatments
Experimental: Experimental arm
Patient having cochlear implantation surgery with RobOtol®.
Other: Control arm
Patient having conventional manual cochlear implantation surgery.
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov