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

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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Emphysema
• Intervention / Treatment: Device: The Pulmonx Zephyr Endobronchial Valve (EBV) 5.5- LP

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 2

Contacts and Locations

Study Locations

• Germany
  • Essen, Germany, 45239
    • Ruhrlandklinik Essen - Universitätsmedizin
• Switzerland
  • Zurich, Switzerland, 8091
    • University Hospital of Zürich
• United Kingdom
  • London, United Kingdom, SW3 6NP
    • Royal Brompton Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The population evaluated will comprise of patients with hyperinflation associated with severe emphysema that are considered appropriate for the procedure by their physician, confirmed to have little to no collateral ventilation and had at least one Zephyr Valve 5.5-LP EBV implanted during the procedure.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treatment; 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; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treated Lobar Volume Reduction (TLVR) changes from Baseline	Treated Lobar Volume Reduction (TLVR) as seen via HRCT at 45-days (absolute and percent changes from baseline).	45 days
Lobar occlusion	Lobar occlusion of the treated lobe at 45-days post-procedure as visualized by HRCT.	45 days
Post-Bronchodilator Forced Expiratory Volume in 1 second (FEV1)	Post-Bronchodilator Forced Expiratory Volume in 1 second (FEV1) at 3-months (absolute and percent changes from baseline).	3 months
Residual Volume (RV)	Residual Volume at 3 months, when available (absolute and percent changes from baseline).	3 months
Total Lung Capacity	Total Lung Capacity (TLC) at 3 months, when available (absolute and percent changes from baseline).	3 months
Inspiratory Capacity	Inspiratory Capacity (IC) at 3 months, when available (absolute and percent changes from baseline).	3 months
Residual Volume/Total Lung Capacity (RV/TLC)	RV/TLC ratio at 3 months, when available (absolute and percent changes from baseline).	3 months
Inspiratory Capacity/Total Lung Capacity (IC/TLC)	IC/TLC ratio at 3 months, when available (absolute and percent changes from baseline).	3 months

Collaborators and Investigators

• Sponsor: Pulmonx Corporation

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2020
• Primary Completion (Actual): August 13, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: November 8, 2019
• First Submitted That Met QC Criteria: November 8, 2019
• First Posted (Actual): November 13, 2019

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Chronic Disease; Pulmonary Emphysema; Emphysema
• Other Study ID Numbers: 630-0025-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes