To collect ongoing safety and effectiveness data of market-released Okami Medical devices
Follow-up visits will be conducted according to a site’s standard care of patients. Data collection will follow the visit schedule within the Appendix
Participants must meet all of the following criteria to be included in the registry: 1. The patient or their legally authorized representative is willing and able to provide informed consent per local requirements 2. Has or will receive treatment with an eligible Okami Medical device 3. Age ; 18 years or older Participants will be excluded from the registry if they meet any of the following criteria: 1. Is or will be inaccessible for registry follow-up 2. Meets exclusion criteria required by local requirements 3. Current or planned participation in a drug or device study that would interfere with participation in this registry or confound the results of this registry in the opinion of the investigator
Protocol Number: 26-0143
More information available at ClinicalTrials.gov: NCT07525518
Principal Investigator