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:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-25 @ 1:28 AM
NCT ID:
NCT02016794
Eligibility Criteria:
Inclusion Criteria:
* Age 21 years or older
* Degenerative cervical condition that requires anterior decompression and fusion in a single or multiple levels
* Degenerative cervical disc disease C3 through Th1 or
* Ruptured and herniated discs C3 through Th1
* Ability to understand the content of the patient information / informed consent form
* Willingness and ability to participate in the registry according to the registry plan (RP)
* Signed and dated IRB / EC-approved written informed consent
Exclusion Criteria:
* Spinal tumor
* Osteoporosis
* Cervical trauma and instability
* Any not medically managed severe systemic disease (ie. infection)
* Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment
* Pregnancy or women planning to conceive within the registry period
* Prisoner
* Participation in any other medical device or medicinal product clinical investigation or registry within the previous month that could influence the results of the present registry
Intraoperative exclusion criteria:
* Intraoperative decision to use implants other than the device under investigation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT02016794
Study Brief:
Protocol Section:
NCT02016794