Endoscopic Lung Volume Reduction by Implantation of Endobronchial Valves (EBV) vs. Intrabronchial Valves (IBV) in Patients With Severe Heterogeneous Emphysema
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Heidelberg University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Improvement in pulmonary function (FEV1 and RV/TLC)
Study Overview
Brief Summary
Patients with advanced heterogeneous emphysema experience improvement in clinical outcomes in the same way following either implantation of endobronchial valves or intrabronchial valves.
Detailed Description
Patient enrollment and data acquisition is to be carried out on a prospective basis. It is planned to enroll a total of 50 patients with advanced heterogeneous emphysema. After decision to undertake endoscopic lung volume reduction by valve implantation patients will be randomised to two treatment arms. 25 patients receive unilateral IBV treatment or unilateral EBV treatment in each case. All patients will undergo treatment at one study centre in Heidelberg.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •pulmonary function: FEV1 < 45 %, RV > 150 %, TLC > 100 %
- •heterogeneous emphysema
Exclusion Criteria
- •homogeneous emphysema
- •significant bronchiectasis
- •severe concomitant diseases
- •pregnancy
Arms & Interventions
Endobronchial valves (EBV)
Complete occlusion of one emphysematous destroyed lobe by implantation of endobronchial valves
Intervention: EBV implantation (Device)
Intrabronchial valves (IBV)
Complete occlusion of one emphysematous destroyed lobe by implantation of intrabronchial valves
Intervention: IBV implantation (Device)
Outcomes
Primary Outcomes
Improvement in pulmonary function (FEV1 and RV/TLC)
Time Frame: 6 months
Secondary Outcomes
- Average changes in 6-minute-walk-distance(6 months)
- Evaluation of valve migration rate(6 months)
- Number of severe adverse events(6 months)
- Average changes in pulmonary function (FEV1, IVC, RV, TLC, RV/TLC)(6 months)
Investigators
Felix JF Herth
Professor MD
Heidelberg University