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 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 1:11 AM
NCT ID:
NCT05049993
Eligibility Criteria:
Inclusion Criteria:
* Subject in the Pyrocarbon IDE Study and has not had the device explanted.
* Patient informed, willing, and able to sign an informed consent form approved by IRB or EC
* Willing and able to comply with the requirements of the study protocol
Exclusion Criteria:
• Subjects who are not able to comply with the study procedures based on the judgment of the assessor will be excluded (e.g. cannot comprehend study questions, inability to keep scheduled assessment times)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT05049993
Study Brief:
Protocol Section:
NCT05049993