Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2025-12-24 @ 5:04 PM
NCT ID:
NCT04610450
Eligibility Criteria:
Inclusion Criteria:
* Subjects scheduled for CI surgery according to clinical routine
* Subjects who will receive a cochlear implant
* Signed and dated informed consent form
Exclusion Criteria:
* Lack of compliance with any inclusion criteria
* Age under 18 years
* Pregnancy
* Distance of the planned trajectory to the facial nerve is \< 0.4 mm as per screening CT scan
* Distance of the planned trajectory to the chorda tympani is \< 0.3 mm as per screening CT scan
* A safe inner ear access cannot be planned for preservation of RW membrane and cochlear structures
* Individuals where image guidance or robotic procedures are not indicated
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04610450
Study Brief:
Protocol Section:
NCT04610450