Trials / Completed
CompletedNCT03746613
Clinal Evaluation of Navigation Based Functional Ear Surgery Using Image Guided and Robotically Assisted Techniques
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- Prof. Vedat Topsakal · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
* Demonstrate the feasibility and efficacy of performing a middle and inner ear access for cochlear implantation procedures in adults. * Validate the procedure workflow including imaging, planning, safety assessment, image to patient registration, robotic drilling, electrode insertion and device implantation. * Validate the system and procedure safety mechanisms. * Collect required data for validation of safety algorithms and procedure workflow optimisation. * Validate the HEARO system.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | HEARO | Robotic system for otological procedures |
Timeline
- Start date
- 2018-09-24
- Primary completion
- 2019-04-27
- Completion
- 2019-06-01
- First posted
- 2018-11-19
- Last updated
- 2019-07-24
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT03746613. Inclusion in this directory is not an endorsement.