Common use of Potential Benefits Clause in Contracts

Potential Benefits. Potential benefits you may experience as a participant in the study include having improved lung function and other improvements that may be associated with improved lung function, such as improved quality of life. If it is determined that control group participants still meet study eligibility criteria and it seems clinically appropriate for them after their 1-year follow-up visit, the study sponsor will pay for these participants to undergo the EBV and bronchoscopy procedure. The primary risks associated with use of the Pulmonx EBV are similar to other bronchoscopic and surgical procedures used to treat emphysema. These are listed below. While this list is comprehensive, there may be other risks that are still unknown. The close monitoring that you will receive, as part of the study, should allow for detection of symptoms, should they be present. This, in turn, should allow for early intervention by your physician if that is necessary. Your physician will review all of the risks below with you so that you understand them. Previous clinical trial experience and experience from other countries around the world, where the EBV device is commercially available, has shown that in some people EBV treatment is associated with having a pneumothorax as a potential complication. A pneumothorax is a condition in which air leaks from the lung into the space between the lung and chest wall. This prevents the healthy lung from working well and can cause chest pain and shortness of breath. As many as 1 in 5 patients may experience a pneumothorax after the study procedure. Most of these tend to occur in the early period following the valve placement and usually resolve after staying in hospital for a few days. Most frequently, a treatment using a small tube to drain out the air is required. In rare cases, a pneumothorax may require a surgical intervention. In addition, there is a chance that it can be a serious and life- threatening complication. Potential Risks (Adverse Events) Acute bronchospasm (spasm of the airway; may result in wheezing or increased shortness of breath) Acute respiratory distress syndrome (sudden, severe injury to lungs) Airway blockage due to implant migration Airway perforation (hole in the airway wall) Airway stenosis (narrowing) Anxiety Aphonia (difficulty talking) Aspiration (inhalation of vomit) Bowel function impairment Bronchial (airway) trauma or ulceration Chest pain COPD exacerbation (acute worsening of COPD symptoms)