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

NCT04610450 | Completed DMC

• 1 other identifier: RCI-NEXT
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Relative ratio of successful electrode array insertions through the drilled direct cochlear access with the HEARO procedure to the total HEARO procedures.

  The primary outcome measure of this study is to explore the relative ratio of the successful electrode array insertions into the cochlea through the drilled direct cochlear access with the HEARO procedure to the total HEARO procedures. Aborted or converted procedures count as procedure in which insertion through the direct cochlea access was not possible. The results will be expressed in relative numbers and in percentage.

  day 0

Secondary Outcomes (9)

• Electrode array insertion outcome

  day 0

• Electrode array insertion outcome

  day 0

• Electrode array insertion outcome

  day 0

• Insertion depth prediction accuracy

  day 0

• Absolute angular accuracy of the drilled tunnel access

  day 0

Study Arms (1)

RCI-BE-10

EXPERIMENTAL

Robot assisted cochlear implant surgery.

Device: HEARO; Device: OTOPLAN

Interventions

HEARO DEVICE

Robotic system for otological procedures

RCI-BE-10

OTOPLAN DEVICE

Otological surgical planning software

RCI-BE-10

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselspital, Bern University Hospital

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marco Caversaccio, Prof. Dr.

  University Hospital Bern (Inselspital)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: October 30, 2020
• Study Start: April 26, 2021
• Primary Completion: November 23, 2022
• Study Completion: November 23, 2022
• Last Updated: November 25, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)