Post-Market Clinical Evaluation of the Zephyr Valve 5.5-LP EBV

Study Overview
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Brief Summary
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This is a Post-Market Evaluation of the Zephyr Valve 5.5-LP EBV to assess Treated Lobar Volume Reduction (TLVR), changes in lung function and the safety profile of the Zephyr Valve treatment with the use of at least one Zephyr Valve 5.5-LP EBV.

Detailed Description
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This is a multi-center, single-arm, prospective, observational study. Approximately 70 study participants undergoing Zephyr Valve treatment with the use of at least one Zephyr Valve 5.5-LP EBV will be enrolled and followed out to 3 months. Assessments will be conducted at 45 days and 3 months. The evaluation will be conducted at up to 6 sites. Patients prescribed Zephyr Valve treatment for their emphysema will be consented and will be enrolled only after: 1) determination of little to no collateral ventilation between target and ipsilateral lobes and 2) implantation of at least one Zephyr Valve 5.5-LP EBV. Baseline data will be collected retrospectively after enrollment of a patient in the Post-Market Evaluation. Performance and safety of the Zephyr Valve treatment with the use of at least one Zephyr Valve 5.5-LP will be evaluated post-treatment based on data collected until 3 months after the treatment.

Official Title
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Post-Market Clinical Evaluation of the Zephyr Valve 5.5-LP EBV for Bronchoscopic Lung Volume Reduction (BLVR) Procedures

Conditions
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Pulmonary Emphysema

Intervention / Treatment
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* Device: The Pulmonx Zephyr Endobronchial Valve (EBV) 5.5- LP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with severe emphysema prescribed treatment with Zephyr Valves Zephyr Valve Treatment with the use of at least one Zephyr Valve 5.5-LP EBV Exclusion Criteria: Patients determined to have collateral ventilation between the target(s) and ipsilateral lobe(s). Patients who undergo Zephyr Valve treatment, but no Zephyr Valve 5.5-LP EBV implanted.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treatment<br>Patients undergoing Zephyr Valve treatment with the use of at least one Zephyr Valve 5.5-LP EBV. | Device: The Pulmonx Zephyr Endobronchial Valve (EBV) 5.5- LP<br>* The Zephyr Valves are implantable bronchial valves intended to control airflow in order to improve lung function in patients with hyperinflation associated with severe emphysema and/or to reduce air leaks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treated Lobar Volume Reduction (TLVR) responders | The percentage of patients treated with the Zephyr Valve 5.5-LP EBV who achieved a Treated Lobar Volume Reduction (TLVR) of the treated lobe (s) of ≥350ml as seen via HRCT at 45-days. | 45 days |