Robotic Assisted Cochlear Implantation Feasibility Study (MIRACI)
Primary Purpose
Sensory Hearing Loss
Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Minimally invasive robotic cochlear implantation
Sponsored by
About this trial
This is an interventional treatment trial for Sensory Hearing Loss focused on measuring cochlear implantation, robotics, image guidance
Eligibility Criteria
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
Sites / Locations
- Inselspital University Hospital Bern
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
Minimally invasive robotic cochlear implantation with custom device
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Number of successfully completed robotic procedures
The number of procedures drilled robotically to the middle ear cavity
The number of successful cochlear implant electrode array insertions
Number of electrode arrays implanted through the key-hole approach to the middle ear cavity
Registration accuracy
Fiducial matching error of patient to image registration
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
Adverse events
Any clinical complications including facial nerve or chorda tympani damage, infection, negative audiological outcomes etc
Blood loss
Intraoperative blood loss (ml)
Postoperative pain
Pain scale and prescribed pain medication
Invasiveness of the intervention
Size of incision (mm)
Full Information
NCT ID
NCT02641795
First Posted
December 19, 2015
Last Updated
October 1, 2018
Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
University of Bern
1. Study Identification
Unique Protocol Identification Number
NCT02641795
Brief Title
Robotic Assisted Cochlear Implantation Feasibility Study
Acronym
MIRACI
Official Title
Robotic Assisted Cochlear Implantation Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
Insufficient enrollment and extended study duration
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
August 22, 2018 (Actual)
Study Completion Date
August 22, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
University of Bern
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensory Hearing Loss
Keywords
cochlear implantation, robotics, image guidance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Minimally invasive robotic cochlear implantation with custom device
Intervention Type
Device
Intervention Name(s)
Minimally invasive robotic cochlear implantation
Primary Outcome Measure Information:
Title
Drilling accuracy
Description
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
Time Frame
Image data acquired during the procedure
Secondary Outcome Measure Information:
Title
Number of successfully completed robotic procedures
Description
The number of procedures drilled robotically to the middle ear cavity
Time Frame
The procedure (day 0)
Title
The number of successful cochlear implant electrode array insertions
Description
Number of electrode arrays implanted through the key-hole approach to the middle ear cavity
Time Frame
The procedure (day 0)
Title
Registration accuracy
Description
Fiducial matching error of patient to image registration
Time Frame
The procedure (day 0)
Title
Time of the robotic procedure and its subparts
Description
Total time of the robotic procedure from opening to closing (mean and standard deviation) and of the subprocesses
Time Frame
The procedure (day 0)
Title
Adverse events
Description
Any clinical complications including facial nerve or chorda tympani damage, infection, negative audiological outcomes etc
Time Frame
day 0-30
Title
Blood loss
Description
Intraoperative blood loss (ml)
Time Frame
The procedure (day 0)
Title
Postoperative pain
Description
Pain scale and prescribed pain medication
Time Frame
day 0-30
Title
Invasiveness of the intervention
Description
Size of incision (mm)
Time Frame
The procedure (day 0)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Caversaccio, MD
Organizational Affiliation
University Hospital Inselspital, Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inselspital University Hospital Bern
City
Bern
ZIP/Postal Code
3008
Country
Switzerland
12. IPD Sharing Statement
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Robotic Assisted Cochlear Implantation Feasibility Study
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