MedTrace Logo

Improving Patient Outcomes by Selective Implantation of the Zephyr EBV - Study

NCT02025205 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2019-08-16

Study results available
· View outcomes & findings →

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

  • COPD Patients With Homogeneous Emphysema
  • Endoscopic Lung Volume Reduction With Endobronchial Valve

Interventions

DEVICE

Endobronchial Valve

Endoscopic Lung Volume Reduction with Zephyr Endobronchial Valve

Sponsors & Collaborators

  • Pulmonx International Sàrl

    lead INDUSTRY

Principal Investigators

  • Arschang Valipour, MD, PhD, FCCP · Ludwig-Boltzmann-Institute for COPD and Respiratory Epidemiology Otto-Wagner-Spital 1140 Wien / Austria

  • Felix Herth (co-principal investigator), MD · Heidelberg University

  • Ralf Eberhardt (co-principal investigator), MD · Heidelberg University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2016-04-30
Completion
2017-03-15

Countries

  • Austria
  • Germany
  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02025205 on ClinicalTrials.gov