Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2026-02-25 @ 9:40 PM
Study NCT ID:
NCT02641795
Status:
TERMINATED
Last Update Posted:
2018-10-03
First Post:
2015-12-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Robotic Assisted Cochlear Implantation Feasibility Study
Sponsor:
Insel Gruppe AG, University Hospital Bern
Organization:
Study Overview
Official Title:
Robotic Assisted Cochlear Implantation Feasibility Study
Status:
TERMINATED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient enrollment and extended study duration
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIRACI
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: