ELEVATE is a device study that will look at the effectiveness of the Pipeline™ Shield Device in treating adults with acutely ruptured brain aneurysms that are shallow and are deemed unsuitable for treating with both clipping (placing a metal clip over the neck of the aneurysm) and coiling (stopping the blood flow into the aneurysm by packing it tightly with small pieces of metal). The primary goals for this study are a complete blocking of the blood vessel without narrowing of the blood vessel and no rebleeding or retreatment of the aneurysm through the 180-day follow-up.
After signing the consent subjects will be treated with the device which is a flow diverter (is a braided metal mesh cylinder that would be implanted across the opening (or ‘neck') of the aneurysm slow down or stop the blood flow into the aneurysm, causing the blood within the aneurysm to clot). The study will follow subjects from consent until the 365-day follow up post procedure. There are some risks associated with study participation such as death, stroke, and device failure. All other risks will be discussed with subjects at time of consent.
Mindfulness is a third wave psychotherapy that has been shown to improve focus and decrease stress and burnout in healthcare professionals. Unfortunately, no study to date has assessed the efficacy of combatting burnout and stress while also improving intraoperative focus in one of the specialties with the highest rate of burnout, neurosurgery. The lengthy time requirements of previous mindfulness interventions are not amenable to the variable schedule of a neurosurgeon. Therefore, the construction of a mindfulness intervention that is short, yet effective is essential to the proper integration of mindfulness into the workflow of neurosurgeons. The purpose of this study is to assess the efficacy of a brief mindfulness intervention on decreasing burnout and stress while improving focus in the operating room.