This is a post market prospective, multi-center study of up to 75 participants at approximately 8 clinical study sites. The objective of the study is to evaluate safety by assessing incidence of device and/or procedure related adverse events.
Protocol Amendment History
2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-08-05; most recent amendment 2025-11-20.
Status change: Not Yet Recruiting → Enrolling by Invitation2025-11-20