European Multi-Center Post Market Study of the IBV Valve System
Recruitment status was Active, not recruiting
The objective of this randomized, blinded, multicenter, controlled study is to compare the performance of the IBV Valve System (treatment group) to a control group receiving a sham bronchoscopy procedure without valve placement.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||European Post Market Study: A Prospective, Randomized, Controlled, Multicenter Study to Evaluate the Performance of the IBV Valve System for the Treatment of Severe Emphysema|
- The difference between the response rates of the treatment and control groups. [ Time Frame: 3-months post randomization ] [ Designated as safety issue: No ]
|Study Start Date:||March 2007|
|Estimated Study Completion Date:||June 2010|
|Estimated Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
|No Intervention: Medical management||
Device: IBV Valve
Placement of IBV Valve in the airways of treatment subjects. Bronchoscopic procedure in control group.
The IBV Valve System (Spiration Inc. Redmond, WA) has CE Mark approval for the treatment of diseased and damaged lung. The devices are one-way valves that can be placed in the airways via flexible bronchoscopy limiting airflow distally. For the treatment of emphysema, valves are placed in airways communicating to the most diseased areas of lung tissue to re-direct airflow to less diseased areas. A multicenter, blinded and randomized study of these valves is being conducted in 7 centers in 6 European countries. The study is evaluating the effectiveness of this therapy for the treatment of upper lobe predominant emphysema in patients with severe to very severe emphysema (GOLD classification 3 to 4) that despite best medical management continue having poor quality of life, severe symptoms and physical limitations. The primary endpoints are to measure and compare responses using the St. George's Respiratory Questionnaire and lung volume changes as measured by CT-scans. Consented patients that meet the strict inclusion criteria have a bronchoscopic procedure and are randomized into treatment or control (no valves) groups. After the procedure, all patients stay blinded to their group assignment and have follow-up evaluations at 1 and 3 months. After the 3-month evaluation, each patient is un-blinded. The treatment group is then scheduled for an additional follow-up at 6 months and the control group is offered valve treatment (rollover) and evaluated approximately 3 months later.
|CHU Saint Pierre|
|Medizinische Hochschule Hannover|
|Spedali Civili di Brescia|
|Clinica Universitaria de Navarra|
|Royal Preston Hospital/Lancashire Teaching Hospitals|
|Preston, United Kingdom|