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Bronchoscopic Lung Volume Reduction Device
Cases for Emphysema (ZEVR Trial)
N/A
Waitlist Available
Research Sponsored by Pulmonx Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 3 years post-procedure
Awards & highlights
Summary
The purpose of this Post-Approval Registry is to gather ongoing safety and effectiveness assessment of the Zephyr Valve treatment in a real-world setting.
Eligible Conditions
- Emphysema
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 3 years post-procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 3 years post-procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence Rate of Pneumothorax from Baseline to 45-days post-procedure
Incidence Rate of Serious Adverse Events (SAEs) of Interest from Baseline to 3 years post-procedure
Secondary outcome measures
Absolute Change in BODE Index Total Score from baseline to 6-months and 12-months post-procedure
Absolute Change in Forced Expiratory Volume in 1 second FEV1 (% Predicted) Post Bronchodilator from baseline to 6-months, 12-months, 24-months and 36-months post-procedure
Absolute Change in Forced Expiratory Volume in 1 second FEV1 (L) Post Bronchodilator from baseline to 6-months, 12-months, 24-months and 36-months post-procedure
+9 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: CasesExperimental Treatment1 Intervention
Zephyr Valve Procedure
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Who is running the clinical trial?
Pulmonx CorporationLead Sponsor
14 Previous Clinical Trials
1,082 Total Patients Enrolled
13 Trials studying Emphysema
1,064 Patients Enrolled for Emphysema
Dennis McHugh, MSStudy DirectorPulmonx Corporation
Christina Kutzavitch, PhDStudy DirectorPulmonx Corporation
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