Clinical Trial to Evaluate the Safety and Effectiveness of the IBV® Valve System for the Treatment of Severe Emphysema
Condition: Emphysema; COPD
MeSH terms: Pulmonary Emphysema; Emphysema
Study type: Interventional

Summary: 
      This trial is for men and women between the ages of 40 and 74 who have a confirmed diagnosis
      of emphysema. The objective of the trial is to determine the safety and effectiveness of the
      IBV Valve at redirecting airflow from diseased portions of the lung to healthier areas to
      achieve improvement in disease-related health status.
    

Detailed description: 
      The IBV Valve Trial is a multi-center clinical trial evaluating the IBV Valve System, a
      non-surgical treatment for patients with emphysema. The IBV Valve System does not require
      traditional surgery or surgical incisions. The valves are placed during a bronchoscopic
      procedure. The IBV Valve System is designed to redirect airflow from diseased portions of the
      lung to healthier areas to achieve improvement in disease-related health status. Although the
      valves are intended to be permanent, they are designed to be removed if necessary.

      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.

      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.
    

Intervention name(s): IBV® Valve System
Intervention type(s): Device
Intervention description(s): The IBV Valve is a small, umbrella shaped device designed to redirect airflow to healthier areas of the lungs. It is implanted without incisions using a bronchoscope.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Emphysema; IBV® Valve; COPD; Shortness of Breath; Spiration