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Clinical Trials in the USA / NCT04186546
Active, not recruiting Observational

Zephyr Valve Registry (ZEVR)

NCT04186546 · tracked via the Priya Life Science USA tracker
Sponsor
Pulmonx Corporation
Phase
Observational
Started
2019-11-25
Last updated
2026-09-17

Condition(s) studied

Emphysema

Investigational drug(s) / intervention(s)

Zephyr Valve Procedure

Zephyr Valve Procedure: The Pulmonx Zephyr Endobronchial Valve is an implantable bronchial valve intended to decrease volume in targeted regions of the lung. It is indicated for the treatment of patients with severe emphysema. The Zephyr Valves are placed in the diseased region of the lung using bronchoscopy. As the diseased region of the lung shrinks in size, healthier regions may expand and function more efficiently, resulting in improved breathing.

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Subjects with severe emphysema considered appropriate for the procedure by the physician. * Subjects who signed an Informed Consent Form to allow data collection. Exclusion Criteria: • Subjects determined to have collateral ventilation between the target(s) and ipsilateral lobe(s).

Primary outcome measure(s)

  • Incidence Rate of Pneumothorax from Baseline to 45-days post-procedure — Baseline to 45-days post-procedure
    The percentage of study participants undergoing the Zephyr Valve Procedure who develop a pneumothorax from the date of the procedure to 45-day post intervention.
  • Incidence Rate of Serious Adverse Events (SAEs) of Interest from Baseline to 3 years post-procedure — Baseline to 3 years post-procedure
    The percentage of study participants who experience a device and/or procedure related SAE including but not limited chronic obstructive pulmonary disease (COPD) exacerbation, hemoptysis, pneumonia, respiratory failure, Valve expectoration and Valve migration

Trial sites (11)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama
University of Chicago Chicago Illinois
Northwestern Medicine Winfield Illinois
Henry Ford Hospital Detroit Michigan
The Lung Center DuBois Pennsylvania
University of Pennsylvania Philadelphia Pennsylvania
Temple University Hospital Philadelphia Pennsylvania
University of Pittsburgh School of Medicine Pittsburgh Pennsylvania
Houston Methodist Houston Texas
Inova Health Fairfax Virginia
Froedtert Memorial-Medical College of Wisconsin Milwaukee Wisconsin

More Pulmonx Corporation trials in the USA

An Evaluation of the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients With Severe Emphysema Recruiting

Other trials for the same condition

A Multi Center Study Testing a New Implant for Adults With Severe Emphysema Recruiting
Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung - Study 3 Recruiting
Xenon MRI to Evaluate Changes to Lung Function Following Bronchoscopic Treatment of Air Trapping in Emphysema Recruiting
STRIVE Post-Market Registry Study Recruiting
Long-term, Open-label Study of SAR447537 (INBRX-101) in Adults With Alpha-1 Antitrypsin Deficiency Emphysema Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04186546 on ClinicalTrials.gov ↗ ← All trials in the USA