Ignite Creation Date:
2024-05-06 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05696171
Status:
RECRUITING
Last Update Posted:
2023-05-31
First Post:
2023-01-13
Brief Title:
Clinical Evaluation of Robot-assisted Cochlear Implant Insertion in Adults Using RobOtol Compared to Manual Insertion
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
Official Title:
Clinical Evaluation of Robot-assisted Cochlear Implant Insertion in Adults Using RobOtol Compared to Manual Insertion
Status:
RECRUITING
Status Verified Date:
2023-05
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:
ROBIICCA
Brief Summary:
The purpose of this study is to evaluate via a randomised controlled design the efficacy of the robotic insertion of cochlear implant versus manual insertion Robotic insertion will be performed using Robotol
This is a three years interventional study involving adults with profound bilateral hearing loss
Eligible subjects will be randomized in two groups robotic insertion or manual insertion Each patient will be followed during 12 months
This is a three years interventional study involving adults with profound bilateral hearing loss
Eligible subjects will be randomized in two groups robotic insertion or manual insertion Each patient will be followed during 12 months
Detailed Description:
Cochlear implants are currently the only option for the rehabilitation of bilateral profound hearing loss Cochlear implant surgery efficacy has been largely demonstrated by numerous studies But despite multiple contributors accuracy and sensitivity of cochlear implant insertion constitute the major and the single factor that surgeons have under control
This manual surgery is performed in an extremely constrained environment and must be as much as delicate as possible to preserve patients residual hearing potential Manual insertion is still largely subject to experience and dexterity of the surgeon Factors associated with the surgical insertion such as incomplete or traumatic insertions translocations destruction of residual hearing have a negative impact on final hearing correction performance
To optimise the hearing results the insertion must be precise linear and atraumatic These conditions may be achieved by robotic insertion
The RobOtol is an innovative robotic assistance system dedicated to ear surgery designed and built in France This is a compact serial robot with 7 degrees of freedom and high resolution allowing lower insertion forces and higher insertion depth than the manual approach Pilot clinical studies have already reported a reduced frequency of translocations via robotic assistance and a reduction in cochlear trauma
The objective of Robiicca is to evaluate via a randomised controlled design the efficacy at 1 year of this robotic technology in cochlear implantation in adultsThe hypothesis is that the optimization of the surgical procedure with the RobOtol will maximize the audiometric results as well as the residual hearing and the vestibular function
This manual surgery is performed in an extremely constrained environment and must be as much as delicate as possible to preserve patients residual hearing potential Manual insertion is still largely subject to experience and dexterity of the surgeon Factors associated with the surgical insertion such as incomplete or traumatic insertions translocations destruction of residual hearing have a negative impact on final hearing correction performance
To optimise the hearing results the insertion must be precise linear and atraumatic These conditions may be achieved by robotic insertion
The RobOtol is an innovative robotic assistance system dedicated to ear surgery designed and built in France This is a compact serial robot with 7 degrees of freedom and high resolution allowing lower insertion forces and higher insertion depth than the manual approach Pilot clinical studies have already reported a reduced frequency of translocations via robotic assistance and a reduction in cochlear trauma
The objective of Robiicca is to evaluate via a randomised controlled design the efficacy at 1 year of this robotic technology in cochlear implantation in adultsThe hypothesis is that the optimization of the surgical procedure with the RobOtol will maximize the audiometric results as well as the residual hearing and the vestibular function
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