Zephyr Valve for Emphysema

(ZEVR Trial)

Not currently recruiting at 10 trial locations

Overseen By Dennis McHugh, MS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Pulmonx Corporation

Disqualifiers: Collateral ventilation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 46

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the Zephyr Valve treatment for individuals with severe emphysema, a lung condition that severely impairs breathing. The goal is to assess the safety and effectiveness of this treatment in real-world settings. Those with severe emphysema, whose doctors believe the procedure could be beneficial, may qualify for this trial. Participants must also consent to data collection for research purposes. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to the potential availability of a new treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for the Zephyr Valve treatment?

Research shows that the Zephyr Valve, a device for treating severe emphysema, is generally well-tolerated. Previous studies found that patients receiving the Zephyr Valve did not experience unusual side effects compared to those receiving standard treatment. The valve reduces lung size, aiding breathing in individuals with damaged lungs.

The device remains on the market, indicating no safety concerns. However, precautions are necessary. Patients with a history of lung surgery or certain infections should use the Zephyr Valve cautiously. Overall, evidence suggests that while risks exist, the treatment is considered safe for many patients. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

The Zephyr Valve Procedure is unique because it offers a minimally invasive option for treating severe emphysema, unlike traditional surgeries like lung volume reduction surgery or lung transplant. This procedure involves placing tiny valves in the airways to block off damaged parts of the lungs, allowing healthier parts to function better. Researchers are excited because it can significantly improve breathing and quality of life without the need for major surgery, offering hope to patients who are not candidates for or wish to avoid more invasive procedures.

What is the effectiveness track record for the Zephyr Valve Procedure?

Research shows that the Zephyr Valve, which participants in this trial will receive, can greatly help people with severe emphysema. Studies have found that patients using the Zephyr Valve experience better lung function, can exercise more, and enjoy a higher quality of life. One study discovered that these valves reduce lung volume, leading to easier breathing and more activity. Another report highlighted long-term benefits, showing that patients had improved lung function for several years. Overall, the Zephyr Valve has a strong record of helping people breathe easier and live better with emphysema. ^{6 7 8 9 10}

Who Is on the Research Team?

Christina Kutzavitch, PhD

Principal Investigator

Pulmonx Corporation

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Treatment

Participants undergo the Zephyr Valve Procedure for treatment of emphysema

1 day

1 visit (in-person)

Post-Treatment Monitoring

Participants are monitored for safety and effectiveness of the Zephyr Valve treatment

3 years

Assessments at 45-days, 6-months, 12-months, 24-months, and 36-months post-procedure

Follow-up

Participants are monitored for long-term safety and effectiveness after treatment

3 years

What Are the Treatments Tested in This Trial?

Interventions

• Zephyr Valve Procedure

How Is the Trial Designed?

Group I: Cases Experimental Treatment 1 Intervention

Zephyr Valve Procedure

Who Is Running the Clinical Trial?

Pulmonx Corporation

Lead Sponsor

Trials

15

Recruited

1,200+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7328183/

Effect of Zephyr Endobronchial Valves on Dyspnea, Activity ... Conclusions: Patients with severe hyperinflated emphysema achieving lung volume reductions with Zephyr Valves experience improvements in multidimensional scores ...

2. journals.lww.com journals.lww.com/annals-of-medicine-and-surgery/fulltext/2025/07000/endobronchial_zephyr_valves_for_bronchoscopic_lung.57.aspx

Endobronchial Zephyr valves for bronchoscopic lung ... Conclusion: Zephyr valves may improve lung function, exercise capacity, and quality of life in patients suffering from severe emphysema. However, the increased ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S095461112400235X

Efficacy and safety of simultaneous combined Zephyr and ... The combined implantation of Zephyr and Spiration valves resulted in significant clinical and functional improvements with an acceptable risk profile.

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/imj.16319

A 6‐year experience of Zephyr endobronchial valves for ... RV improvement was sustained at 3.88 ± 0.89 L (45.6% of patients), a fall from baseline of −640 mL (95% CI: −360 to −920, P < 0.0001).

5. investors.pulmonx.com investors.pulmonx.com/news-releases/news-release-details/zephyrr-valve-treatment-provides-long-term-quality-life-and-lung

Zephyr® Valve Treatment Provides Long-Term Quality of Life ... The study shows that the Zephyr Valves provide significant benefits to patients including improvements over baseline in lung function and ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf18/P180002B.pdf

summary of safety and effectiveness data (ssed) The Zephyr valve is for treating severe emphysema by reducing lung volume. It has not been withdrawn for safety or effectiveness reasons.

7. pulmonx.com pulmonx.com/prescriptive-information/

Pulmonx | Zephyr Valve Prescriptive Information The Zephyr Valve is contraindicated for: Patients for whom bronchoscopic procedures are contraindicated; Evidence of active pulmonary infection; Patients with ...

8. zephyrvalves.com zephyrvalves.com/prescriptive-information/

Important Prescriptive Information about the Zephyr Valve Warnings: The Zephyr Valve should be used with caution and only after careful consideration in patients with: Prior lung transplant, LVRS, median sternotomy, or ...

9. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf18/P180002C.pdf

Zephyr Endobronchial Valve System Instructions for Use The safety of the Zephyr EBV System was assessed by comparing adverse event profiles of the Zephyr EBV and SoC group subjects for the Treatment Period (day of ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8743904/

Endobronchial Valve (Zephyr) Treatment in Homogeneous ... The present report provides longer term safety and effectiveness data on Zephyr valve treatment in patients with homogeneous emphysema. ... The short-term safety ...