Trials / Completed
CompletedNCT02025205
Improving Patient Outcomes by Selective Implantation of the Zephyr EBV - Study
A Multicentre, Prospective, Randomized, Controlled, One-way Crossover Investigation of Endobronchial Valve (EBV) Therapy vs. Standard of Care (SoC) in Homogeneous Emphysema
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 93 (actual)
- Sponsor
- Pulmonx International Sàrl · Industry
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this prospective, randomized, controlled, one-way crossover study is to assess and compare the efficacy of the Zephyr endobronchial valves vs. Standard of Care (SoC) in patients suffering from COPD with Homogeneous Emphysema. Patients will be followed up for 12 months after randomization. Patients in the SoC arm will crossover to the EBV treatment arm after the 6-month visit and will be followed up for 6 additional months.The primary objective is the variation of FEV1 between baseline and 3-month follow-up visit. The secondary objectives will evaluate quality of life, exercise capacity, dyspnea (including BODE index) changes, target lobe volume reduction, as well as safety outcomes.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Endobronchial Valve | Endoscopic Lung Volume Reduction with Zephyr Endobronchial Valve |
Timeline
- Start date
- 2014-08-01
- Primary completion
- 2016-04-01
- Completion
- 2017-03-15
- First posted
- 2013-12-31
- Last updated
- 2019-08-16
- Results posted
- 2019-08-16
Locations
8 sites across 3 countries: Austria, Germany, Netherlands
Source: ClinicalTrials.gov record NCT02025205. Inclusion in this directory is not an endorsement.