The Performance of a Robot-assisted Minimally Invasive Direct Cochlear Access for Cochlear Implantation

NCT ID: NCT04610450

Last Updated: 2022-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-26
• Study Completion Date: 2022-11-23

Brief Summary

The cochlear implant is a neural prosthesis and has been the gold standard treatment for severe to profound sensorineural hearing loss over several decades. The surgical procedure for cochlear implantation aims to atraumatically insert the electrode array of the cochlear implant into the cochlea. However, due to the location of the cochlea inside the skull, the surgeon is required to create an access from the surface of the temporal bone to the cochlea (inner ear). In conventional methods, this access is acquired by removal of portions of the mastoid bone through a mastoidectomy and posterior tympanotomy. The outcome and success of the conventional procedure varies due to mainly two factors: surgeon skill and subject anatomical variation. To overcome these variables toward a more consistent and less invasive cochlear implantation surgery, the development of robotic and image guided cochlear implantation has taken place. This study primarily aims to explore the performance of robotic cochlear implantation surgery.

Conditions

Sensorineural Hearing Loss

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RCI-BE-10

Robot assisted cochlear implant surgery.

Group Type: EXPERIMENTAL

HEARO

Intervention Type: DEVICE

Robotic system for otological procedures

OTOPLAN

Intervention Type: DEVICE

Otological surgical planning software

Interventions

HEARO

Robotic system for otological procedures

Intervention Type: DEVICE

OTOPLAN

Otological surgical planning software

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subjects scheduled for CI surgery according to clinical routine
• Subjects who will receive a cochlear implant
• Signed and dated informed consent form

• Age under 18 years
• Pregnancy
• Distance of the planned trajectory to the facial nerve is < 0.4 mm as per screening CT scan
• Distance of the planned trajectory to the chorda tympani is < 0.3 mm as per screening CT scan
• A safe inner ear access cannot be planned for preservation of RW membrane and cochlear structures
• Individuals where image guidance or robotic procedures are not indicated

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marco Caversaccio, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Bern (Inselspital)

Locations

Inselspital, Bern University Hospital

Bern, , Switzerland

Countries

Switzerland

Other Identifiers

RCI-NEXT

Identifier Type: -

Identifier Source: org_study_id