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 @ 10:49 PM
Ignite Modification Date:
2025-12-24 @ 10:49 PM
NCT ID:
NCT02918669
Eligibility Criteria:
Inclusion Criteria:
* Participant in coflex IDE Study
* Willing and able to give informed consent
* Spinous process fracture identified by site and/or radiographic lab at 24 months
Exclusion Criteria:
* Subjects who died, were withdrawn or withdrew consent to participate in the study
* Subjects who are pregnant, or planning to become pregnant, during the course of this study
* Subjects who have cancer, whether active or in remission
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02918669
Study Brief:
Protocol Section:
NCT02918669