Understanding How Safe and Well the Okami Medical LOBO Device Works
This study is looking for adults age 18 and older who are using or will be using the Okami Medical LOBO Vascular Occluder Device to treat their condition.
Why this Research Matters
The Okami Medical LOBO Vascular Occluder Device (LOBO) is already approved by the FDA for use in patients. Researchers want to learn more about how well it works in real world settings. Before you can join, the study team will review your health records and ask questions to see if you qualify. If you join, you will not need to do anything extra. You will keep getting your normal care from your health care team. The study team will collect information about your procedure, such as what happens during it, and will review images taken before and after the procedure. This will help them see how well the LOBO device works. After, researchers will collect more information and ask you questions about your health, either in person or over the phone. Your participation in the study may last up to 3 years, depending on your condition. You will not be paid for being in this study. You and your insurance will still pay for your normal medical care, but there will be no extra costs for being in the study.
Who can Participate
You may be able to join this study if you are 18 or older and have or will receive treatment with an eligible LOBO device. You cannot join this study if you are in, or plan to join, another drug or device study that would affect this study.
Study ID
Protocol Number: 26-0143
More information available at ClinicalTrials.gov: NCT07525518
Meet the Team
Principal Investigator