Clinical Evaluation of the Serenity River Stent System to Treat Idiopathic Intracranial Hypertension The River Trial
This study enrolls people who have been diagnosed with Idiopathic Intracranial Hypertension (IIH), or high pressure in the brain due to unknown reasons. The purpose of this study is to find out if an investigational (experimental) device, which has not been approved by the FDA yet, is safe and can help treat patients who suffer from vision problems and headaches related to IIH. The device being tested is a stent that will reopen the narrowed veins in the brain as other small studies have shown this to be beneficial to patients with IIH.
This study will last approximately 5 years in order to properly monitor your improvement and symptoms. There will be an initial screening visit where your doctor will perform imaging of your brain, blood tests, and sampling your spinal fluid to see if you are a good fit for the study. If you and your doctor decide to move forward, the procedure will occur using a minimally invasive technique. You will be required to spend one night in the hospital and then 8 follow up visits over 5 years. This study takes place at UBMD Neurosurgery clinics and Buffalo General Medical Center/ Gates Vascular Institute in Buffalo NY.
(CSR # 180311564249) The purpose of this study is to test the safety of re-opening a narrowing in the dural sinus of the brain in subjects with IIH and see if that improves visual problems, headaches, and quality of life.
People ages 18+
Diagnosis of IIH with symptoms of headaches or vision problems
Let us know how the study team can reach you.
If you do not hear back within 2 business days, reach out to the study team directly at the contact information above or email email@example.com and someone will assist you.