The department of pulmonary, critical care and sleep medicine is conducting a trial evaluating the safety and effectiveness of the IBV valve system for patients with severe emphysema. This trial is funded by Spiration, Inc. and the principal investigator is Muhanned Abu-Hijleh, MD.
About the study
The IBV valve trial is a randomized, blinded trial. This means that participants are divided into two groups but do not know to which group they have been assigned. The IBV valve treatment group receives valves, and the control group does not. A random selection process decides the group assignments (participants will not be able to choose their group). In the trial, everyone will have a 50 percent chance (similar to a coin toss) to be assigned to one group or the other.
All participants in this clinical trial will:
The procedure, all testing, and doctor visits are provided at no cost to participants of both the IBV valve treatment group and the control group. Parking and travel reimbursement costs are also available.
After the trial is completed
At the completion of their 6-month visit, participants will be told if they were assigned to the treatment group or the control group. If participants were assigned to the group that did not receive valves (the control group), they will be given the option to be re-evaluated by the clinical trial doctor, to determine if they can have valve treatment.
To participate you must:
To learn more, contact Erin Richard at 401-444-7748.