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NCT02641795: MIRACI
Robotic Assisted Cochlear Implantation Feasibility Study
NA trial testing Minimally invasive robotic cochlear implantation in Sensory Hearing Loss in 9 participants. Terminated before completion.
22 August 2018
Quick facts
| Lead sponsor | Insel Gruppe AG, University Hospital Bern |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 9 |
| Start date | 1 July 2016 |
| Primary completion | 22 August 2018 |
| Estimated completion | 22 August 2018 |
| Sites | 1 location across Switzerland |
Drugs / interventions tested
- Minimally invasive robotic cochlear implantation
Conditions studied
- Sensory Hearing Loss — all drugs for Sensory Hearing Loss →
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):
-
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 -
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
Verify or expand the search:
- PubMed search for NCT02641795
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Insel Gruppe AG, University Hospital Bern trials
Trials by the same sponsor.
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- NCT07478536 — Stockholm3 Test Validation in Men on Active Surveillance in Switzerland (CHAS3 Trial) · not yet recruiting
- NCT07201506 — Real-Time Intracardiac Echocardiography for Ventricular Arrhythmia Ablation · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02641795 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Insel Gruppe AG, University Hospital Bern
- Last refreshed: 3 October 2018
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