Sensory Hearing LossMIRACINCT02641795
Robotic Assisted Cochlear Implantation Feasibility Study
A study testing Minimally invasive robotic cochlear implantation in people with Sensory Hearing Loss, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sensory Hearing Loss
- What is being tested?
- Minimally invasive robotic cochlear implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2016to 22 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Pregnancy
- Anatomical malformation of the middle or inner ear or unusual facial nerve course
- Lack of compliance with any inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Sensory Hearing Loss
- Being tested
- Minimally invasive robotic cochlear implantation
- Keywords
- cochlear implantation, robotics, image guidance
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive robotic cochlear implantationDevice
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Minimally invasive robotic cochlear implantation with custom device Receives: Device: Minimally invasive robotic cochlear implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Image data acquired during the procedure
Secondary outcomes (8)
Number of successfully completed robotic procedures
The number of procedures drilled robotically to the middle ear cavity
Measured: 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
Measured: The procedure (day 0)
Registration accuracy
Fiducial matching error of patient to image registration
Measured: 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
Measured: The procedure (day 0)
Adverse events
Any clinical complications including facial nerve or chorda tympani damage, infection, negative audiological outcomes etc
Measured: day 0-30
Blood loss
Intraoperative blood loss (ml)
Measured: The procedure (day 0)
Postoperative pain
Pain scale and prescribed pain medication
Measured: day 0-30
Invasiveness of the intervention
Size of incision (mm)
Measured: The procedure (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study start1 Jul 2016
- Primary completion22 Aug 2018
- Study completion22 Aug 2018
Why it stopped: Insufficient enrollment and extended study duration
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensory Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern
- Responsible party
- Sponsor
- Investigators
- Marco Caversaccio, MD, Principal investigator, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02641795
- Sponsor's protocol ID
- CIV-13-12-011779
- Other IDs
- PB_2017-0031, 2013-MD-0042, CIV-13-12-011779
- Acronym
- MIRACI
- Status last verified
- Oct 2018
- First submitted
- 19 Dec 2015
- Last updated
- 3 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Assisted Cochlear Implantation Feasibility Study
- ClinicalTrials.gov ID
- NCT02641795
- Acronym / sponsor ID
- MIRACI / CIV-13-12-011779
- Conditions
- Sensory Hearing Loss
- Keywords
- cochlear implantation, robotics, image guidance
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment and extended study duration
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- University of Bern
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 22 Aug 2018 (actual)
- Study completion
- 22 Aug 2018 (actual)
- First posted
- 29 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Minimally invasive robotic cochlear implantationMinimally invasive robotic cochlear implantation with custom device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- Pregnancy
- Anatomical malformation of the middle or inner ear or unusual facial nerve course
- Lack of compliance with any inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimally invasive robotic cochlear implantation | Device | Experimental |
Primary outcome
Drilling accuracy
Time frame: Image data acquired during the procedure
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
8 secondary outcomes
Number of successfully completed robotic procedures
Time frame: The procedure (day 0)
The number of successful cochlear implant electrode array insertions
Time frame: The procedure (day 0)
Registration accuracy
Time frame: The procedure (day 0)
Time of the robotic procedure and its subparts
Time frame: The procedure (day 0)
Adverse events
Time frame: day 0-30
Blood loss
Time frame: The procedure (day 0)
Postoperative pain
Time frame: day 0-30
Invasiveness of the intervention
Time frame: The procedure (day 0)
Results and safety
The study was stopped early (reason given: Insufficient enrollment and extended study duration). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Caversaccio, MD principal investigator
Insel Gruppe AG, University Hospital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally invasive robotic cochlear implantation in people with Sensory Hearing Loss, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient enrollment and extended study duration). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drilling accuracy (time frame: Image data acquired during the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2018.