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 @ 10:44 PM
Ignite Modification Date:
2025-12-24 @ 10:44 PM
NCT ID:
NCT05258435
Eligibility Criteria:
Inclusion Criteria:
1. Subject was enrolled in the Simplify Disc post approval study (NCT04630626) at a participating study site
2. Subject understands the conditions of enrollment and is willing to sign an informed consent form to participate in the study
Exclusion Criteria:
1. Subject had an SSI at the index level during the post approval study (NCT04630626)
2. Subject was withdrawn or withdrew consent to participate in the post approval study (NCT04630626)
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT05258435
Study Brief:
Protocol Section:
NCT05258435