Robotic Assisted Cochlear Implantation Feasibility Study (MIRACI)

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.

Study Overview

• Status: Terminated
• Conditions: Sensory Hearing Loss
• Intervention / Treatment: Device: Minimally invasive robotic cochlear implantation

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3008
    • InselSpital University Hospital Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Minimally invasive robotic cochlear implantation with custom device	Device: Minimally invasive robotic cochlear implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of successfully completed robotic procedures	The number of procedures drilled robotically to the middle ear cavity	The procedure (day 0)
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)
Registration accuracy	Fiducial matching error of patient to image registration	The procedure (day 0)
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)
Adverse events	Any clinical complications including facial nerve or chorda tympani damage, infection, negative audiological outcomes etc	day 0-30
Blood loss	Intraoperative blood loss (ml)	The procedure (day 0)
Postoperative pain	Pain scale and prescribed pain medication	day 0-30
Invasiveness of the intervention	Size of incision (mm)	The procedure (day 0)

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Collaborators: University of Bern
• Investigators: Principal Investigator: Marco Caversaccio, MD, University Hospital Inselspital, Bern

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): August 22, 2018
• Study Completion (Actual): August 22, 2018

Study Registration Dates

• First Submitted: December 19, 2015
• First Submitted That Met QC Criteria: December 23, 2015
• First Posted (Estimate): December 29, 2015

Study Record Updates

• Last Update Posted (Actual): October 3, 2018
• Last Update Submitted That Met QC Criteria: October 1, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: robotics; cochlear implantation; image guidance
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Hearing Loss, Sensorineural
• Other Study ID Numbers: CIV-13-12-011779 (Other Identifier: EUDAMED); PB_2017-0031 (Other Identifier: Ethics commision Bern, Switzerland); 2013-MD-0042 (Other Identifier: Swissmedic (regulatory authority))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No