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We are doing this study to collect data about the use and safety of the GORE TAG Conformable Thoracic Stent Graft®. This device is approved by the FDA for the endovascular repair of medical conditions of the aorta (the large blood vessel that runs inside the chest and abdomen).
In this study, people will be treated with the Gore TBE device as part of their regular surgery planned by their doctor. The study will collect information from normal follow up visits for up to ten years. Participants will also be asked to fill out a questionnaire before surgery and again at each follow up visit to help doctors understand how they are doing over time.
If you are able to join this study, you will be placed by chance into one of three groups. One group will get 225 milligrams of the study drug GSK6519754, another will get 300 milligrams, and the third group will get a placebo, which has no medicine. You will get your assigned injection once every four weeks for four years. During the study, which lasts a little over four years, you will have at least fifty four visits. At these visits, you will have blood tests, body and liver scans, ultrasounds, a liver biopsy, and questionnaires to check your health and how the treatment is working.
If you can join this study, you will be placed by chance into one of three groups. One group will get 225 milligrams of the study medicine called GSK6519754, another group will get 300 milligrams, and the third group will get a placebo, which has no medicine. Most people will receive the study medicine. You will get the injection once every four weeks for several years. During the study, you will come to the clinic many times. At these visits, doctors will do blood tests, body and liver scans, ultrasounds, and ask you to fill out questionnaires to check your health and how the treatment is working.
Completing an 8 question survey
If a child joins this study, they will be placed into one of two groups by chance. One group will receive a medicine called Cipepofol, and the other group will receive a medicine called Propofol. These medicines are given through a vein to help the child fall asleep before surgery. Most children will receive Cipepofol, while a smaller number will receive Propofol. All children will still receive normal anesthesia care during surgery. Before surgery, there will be a screening visit with tests such as a physical exam, blood tests, urine tests, heart checks, and vital signs. On the day of surgery, more checks will be done. After surgery, the study team will call three times to see how the child is doing. Participation lasts for up to 29 days after surgery.