Last reviewed · How we verify
NCT03746613: EAR2OS
Clinal Evaluation of Navigation Based Functional Ear Surgery Using Image Guided and Robotically Assisted Techniques
NA trial testing HEARO in Sensorineural Hearing Loss in 3 participants. Completed in 1 June 2019.
27 April 2019
Quick facts
| Lead sponsor | Prof. Vedat Topsakal |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 3 |
| Start date | 24 September 2018 |
| Primary completion | 27 April 2019 |
| Estimated completion | 1 June 2019 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- HEARO
Conditions studied
- Sensorineural Hearing Loss — all drugs for Sensorineural Hearing Loss →
Sponsor
Prof. Vedat Topsakal
Who can join
18 and older, any sex, with Sensorineural Hearing Loss. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To assess the feasibility of achieving a minimally invasive access to the inner ear through the navigation-based HEARO procedure and subsequently insert the electrode array of the cochlear implant through the access.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
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 -
Audiological outcomes of robot-assisted cochlear implant surgery.
Heuninck E, Van de Heyning P, Van Rompaey V, Mertens G, et al · · 2023 · cited 8× · PMID 37043021 · DOI 10.1007/s00405-023-07961-7
Verify or expand the search:
- PubMed search for NCT03746613
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of HEARO
Trials testing the same drug.
- NCT04610450 — The Performance of a Robot-assisted Minimally Invasive Direct Cochlear Access for Cochlear Implantation · NA · completed
- NCT04102215 — The Efficacy of a Minimally Invasive Direct Cochlear Access Via the HEARO Procedure · NA · unknown
Other recruiting trials for Sensorineural Hearing Loss
Currently open trials in the same condition.
- NCT07505667 — Yiyuancong for the Treatment of Sudden Sensorineural Hearing Loss · NA · recruiting
- NCT06507007 — Genetic and Epigenetic Background of Inner Ear Dysfunction in Turner Syndrome · recruiting
- NCT07364747 — Protective Effect of Acetylcysteine Against Cisplatinum-Induced Ototoxicity: A Randomized Controlled Trial · Phase 2 · recruiting
- NCT06495268 — Healthy heaAring for Healthy Ageing: Data-driven Hearing Rehabilitation Intervention to Promote Healthy Hearing · NA · active not recruiting
- NCT06226558 — Long-Term Outcomes of Children With Congenital CMV in New York State · recruiting
Other Prof. Vedat Topsakal trials
Trials by the same sponsor.
- NCT04102215 — The Efficacy of a Minimally Invasive Direct Cochlear Access Via the HEARO Procedure · NA · unknown
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 NCT03746613 (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 Prof. Vedat Topsakal
- Last refreshed: 24 July 2019
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/NCT03746613.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing