Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06248398
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-08
First Post:
2023-12-08
Brief Title:
Impact of Robotic Cochlear Implantation on Hearing Performance in Noise
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Impact of Robotic Cochlear Implantation on Hearing Performance in Noise
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ROBOT-IC-BRUIT
Brief 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 patientsyear
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
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 patientsyear
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
Detailed Description:
In the case of severe 70 to 90dB loss and profound 90dB loss hearing loss when conventional hearing aids no longer provide sufficient benefit cochlear implantation remains the only possible solution for hearing rehabilitation In implanted patients a clear improvement in communication in silence is observed but almost all patients have difficulty understanding speech in noisy environments Cochlear implantation involves inserting an electrode holder into the cochlea during a surgical procedure under general anesthesia The insertion of the electrode holder must be as minimally traumatic as possible in order to preserve the cochlear structures and avoid post-operative fibrosis that could impact the auditory outcomes
The conventional method of this surgery is the manual insertion of the electrode holder In recent years robotic assistance the RobOtol has been developed with the aim of avoiding the jerks of the surgeons hand and improving the precision of the insertion RobOtol has had its CE marking since 2016 and is used in several hospitals in France and abroad
The conventional method of this surgery is the manual insertion of the electrode holder In recent years robotic assistance the RobOtol has been developed with the aim of avoiding the jerks of the surgeons hand and improving the precision of the insertion RobOtol has had its CE marking since 2016 and is used in several hospitals in France and abroad
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A00837-38 | OTHER | NIDRCB | None |