Overview

This trial is active, not recruiting.

Conditions copd, heterogeneous emphysema
Treatment elvr (endoscopic lung volume reduction) with zephyr valve
Sponsor Pulmonx, Inc.
Start date December 2013
End date September 2016
Trial size 97 participants
Trial identifier NCT02022683, 630-0015/A

Summary

To compare the clinical outcomes of Endoscopic Lung Volume Reduction using Pulmonx Zephyr Endobronchial Valve (EBV) vs. Standard of Care (SoC) in the treatment of heterogeneous emphysema patients in a controlled trial design setting.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients are implanted Zephyr EBV
elvr (endoscopic lung volume reduction) with zephyr valve
Standard Medical Care
(No Intervention)
Patients are given Standard of Care treatment

Primary Outcomes

Measure
Change in FEV1
time frame: Between baseline and 3 months

Secondary Outcomes

Measure
Changes in St George's Respiratory Questionnaire, 6-Min Walk Test, BODE index, mMRC score,
time frame: Betwenn baseline and 3, 6, 12, 18, and 24 months

Eligibility Criteria

Male or female participants at least 40 years old.

Inclusion Criteria: - Heterogeneous emphysema - 15% pred < or = FEV1 < or = 45% pred - TLC > 100% and RV > or = 180% - 150 m < or = 6MWT < or = 450 m - No collateral ventilation Exclusion Criteria: - Contraindication to bronchoscopy - Active pulmonary infection - History of 2 or more exacerbations with hospitalization over the past 12 months - Known pulmonary hypertension - Prior LVR or LVRS procedure - Pregnant or lactating woman - Hypercapnia - Current diagnosis of asthma - > 25 mg Prednisolon / day - CV in the target lobe or inconclusive Chartis assessment

Additional Information

Official title A Multi-center, Prospective, Randomized, Controlled Trial of Endobronchial Valve Therapy vs. Standard of Care in Heterogeneous Emphysema
Principal investigator Gunnar Hillerdal, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Pulmonx, Inc..