Pulmonary: IBV Valve Study for People with Severe Emphysema

Pulmonary:
IBV Valve Study for People with Severe Emphysema

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:

• Receive a diagnostic bronchoscopy that will allow an expert in lung health to evaluate their lungs
• Be under the care of a highly qualified lung doctor for the entire time they are in the trial, regardless of whether they are in the treatment group or the control group
• Receive regular periodic check-ups and health assessments throughout the 6 month trial period

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:

• Have been diagnosed with emphysema of the upper lobes of the lung
• Are able to participate in standard exercise testing
• Have stopped smoking for at least 4 months and will not smoke while in the study
• Be able to commit to 4 visits for health assessment testing
  
  

To learn more, contact Erin Richard at 401-444-7748.