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NCT02641795: MIRACI

Robotic Assisted Cochlear Implantation Feasibility Study

Terminated NA Last updated 3 October 2018
What this trial tests

NA trial testing Minimally invasive robotic cochlear implantation in Sensory Hearing Loss in 9 participants. Terminated before completion.

Timeline
1 July 2016
Primary endpoint
22 August 2018
22 August 2018

Quick facts

Lead sponsorInsel Gruppe AG, University Hospital Bern
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment9
Start date1 July 2016
Primary completion22 August 2018
Estimated completion22 August 2018
Sites1 location across Switzerland

Drugs / interventions tested

Conditions studied

Sponsor

Insel Gruppe AG, University Hospital Bern

Who can join

18 and older, any sex, with Sensory Hearing Loss. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Robotic middle ear access for cochlear implantation: First in man.
    Caversaccio M, Wimmer W, Anso J, Mantokoudis G, et al · · 2019 · cited 57× · PMID 31374092 · DOI 10.1371/journal.pone.0220543
  2. First Study in Men Evaluating a Surgical Robotic Tool Providing Autonomous Inner Ear Access for Cochlear Implantation.
    Topsakal V, Heuninck E, Matulic M, Tekin AM, et al · · 2022 · cited 29× · PMID 35386404 · DOI 10.3389/fneur.2022.804507

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Other Insel Gruppe AG, University Hospital Bern trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02641795.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing