Robotic Assisted Cochlear Implantation Feasibility Study

NCT ID: NCT02641795

Last Updated: 2018-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-01

Study Completion Date

2018-08-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sensory Hearing Loss

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental

Minimally invasive robotic cochlear implantation with custom device

Group Type EXPERIMENTAL

Minimally invasive robotic cochlear implantation

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Minimally invasive robotic cochlear implantation

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Bern

OTHER

Sponsor Role collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marco Caversaccio, MD

Role: PRINCIPAL_INVESTIGATOR

Insel Gruppe AG, University Hospital Bern

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Inselspital University Hospital Bern

Bern, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PB_2017-0031

Identifier Type: OTHER

Identifier Source: secondary_id

2013-MD-0042

Identifier Type: OTHER

Identifier Source: secondary_id

CIV-13-12-011779

Identifier Type: OTHER

Identifier Source: secondary_id

CIV-13-12-011779

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.