Robotic Assisted Cochlear Implantation Feasibility Study (MIRACI)

Insel Gruppe AG, University Hospital Bern

Status: Terminated

Conditions: Sensory Hearing Loss

Treatments: Device: Minimally invasive robotic cochlear implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT02641795

CIV-13-12-011779 (Other Identifier)

PB_2017-0031 (Other Identifier)

2013-MD-0042 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Experimental

Experimental group

Description:

Minimally invasive robotic cochlear implantation with custom device

Treatment:

Device: Minimally invasive robotic cochlear implantation