Robotic Assisted Cochlear Implantation Feasibility Study

Sensory Hearing Loss Clinical Trial

— MIRACI  

Official title:

Robotic Assisted Cochlear Implantation Feasibility Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02641795
• Other study ID #: CIV-13-12-011779
• Secondary ID: PB_2017-00312013
• Status: Terminated
• Phase: N/A
• Start date: July 1, 2016
• Est. completion date: August 22, 2018

Study information

• Verified date: October 2018
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A first in man clinical trial to asses the the use of am image guided robotic system to safely and effectively create a minimally invasive access tunnel to the middle ear cavity to allow access to the round window for cochlear implant electrode insertion.

Description:

A first in man feasibility study of an image guided robotic system for performing a key-hole approach to the middle ear cavity.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: August 22, 2018
• Est. primary completion date: August 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Geographically and physically able to attend scheduled evaluations and follow-up appointments

• Indicated for cochlear implantation

• Age 18 years or older

• Fluent in German or French

• Sufficient facial recess size ( > 2.5 mm between the facial nerve and chorda tympani)

Exclusion Criteria:

• Pregnancy

• Anatomical malformation of the middle or inner ear or unusual facial nerve course

• Lack of compliance with any inclusion criteria

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Sensorineural
• Sensory Hearing Loss

Intervention

Device:
• Minimally invasive robotic cochlear implantation

Locations

Country	Name	City	State
Switzerland	Inselspital University Hospital Bern	Bern

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drilling accuracy	The lateral distance between the center lines of the planned and drilled tunnel positions at the level of the facial nerve measured from medical image data	Image data acquired during the procedure
Secondary	Number of successfully completed robotic procedures	The number of procedures drilled robotically to the middle ear cavity	The procedure (day 0)
Secondary	The number of successful cochlear implant electrode array insertions	Number of electrode arrays implanted through the key-hole approach to the middle ear cavity	The procedure (day 0)
Secondary	Registration accuracy	Fiducial matching error of patient to image registration	The procedure (day 0)
Secondary	Time of the robotic procedure and its subparts	Total time of the robotic procedure from opening to closing (mean and standard deviation) and of the subprocesses	The procedure (day 0)
Secondary	Adverse events	Any clinical complications including facial nerve or chorda tympani damage, infection, negative audiological outcomes etc	day 0-30
Secondary	Blood loss	Intraoperative blood loss (ml)	The procedure (day 0)
Secondary	Postoperative pain	Pain scale and prescribed pain medication	day 0-30
Secondary	Invasiveness of the intervention	Size of incision (mm)	The procedure (day 0)