IBV® Valve Trial Pre-screener for Interested Candidates
The IBV Valve Trial is a randomized, blinded study, which means everyone who participates will be assigned to one of two groups; the IBV Valve Treatment Group or the Control Group. A random selection process will decide the group assignments. In the study everyone has a 50% chance of being assigned to one group or the other.
The goal of this study is to determine the safety and effectiveness of an investigational device, which is placed in the lungs of people with severe emphysema. These small devices are placed into portions of the lungs. The valves are placed without an incision using a flexible bronchoscope. These small umbrella shaped, one-way valves are designed to redirect airflow to healthier portions of the lung and intended to improve overall health status and quality of life. The information you provide will help determine if you may be eligible to participate in this phase of the study.
If you participate in the study, your participation will last from 6 to 12 months. If you participate and receive valves you will be followed up to 5 years.
If you qualify and decide to participate, you will be required to have at least one overnight stay in the hospital and you may also be required to participate in up to 4 day-long visits for health assessment tests conducted at a research site.
All study-related medical exams, procedures and laboratory tests are provided to qualified participants at no cost.
In order to determine if you pre-qualify for the Spiration IBV Valve Trial, we will need to ask you some personal questions about your medical history. Some of the questions may be sensitive, such as questions about age, birth control, etc. Answering these questions is voluntary. You do not have to answer any questions you do not want to answer and you may stop at any time. If the questionnaire is incomplete, it may be disqualified.
Do you grant your permission to continue?
