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NCT Number: NCT04161235

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

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.

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Key information

Conditions

Pulmonary Emphysema Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruhrlandklinik Essen - Universitätsmedizin, Essen, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The Pulmonx Zephyr Endobronchial Valve (EBV) 5.5- LP

Device

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.

Primary outcomes

  1. Treated Lobar Volume Reduction (TLVR) responders

    Time frame: 45 days

    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.

Other outcomes

  1. Treated Lobar Volume Reduction (TLVR) changes from Baseline

    Time frame: 45 days

    Treated Lobar Volume Reduction (TLVR) as seen via HRCT at 45-days (absolute and percent changes from baseline).

  2. Lobar occlusion

    Time frame: 45 days

    Lobar occlusion of the treated lobe at 45-days post-procedure as visualized by HRCT.

  3. Post-Bronchodilator Forced Expiratory Volume in 1 second (FEV1)

    Time frame: 3 months

    Post-Bronchodilator Forced Expiratory Volume in 1 second (FEV1) at 3-months (absolute and percent changes from baseline).

  4. Residual Volume (RV)

    Time frame: 3 months

    Residual Volume at 3 months, when available (absolute and percent changes from baseline).

  5. Total Lung Capacity

    Time frame: 3 months

    Total Lung Capacity (TLC) at 3 months, when available (absolute and percent changes from baseline).

  6. Inspiratory Capacity

    Time frame: 3 months

    Inspiratory Capacity (IC) at 3 months, when available (absolute and percent changes from baseline).

  7. Residual Volume/Total Lung Capacity (RV/TLC)

    Time frame: 3 months

    RV/TLC ratio at 3 months, when available (absolute and percent changes from baseline).

  8. Inspiratory Capacity/Total Lung Capacity (IC/TLC)

    Time frame: 3 months

    IC/TLC ratio at 3 months, when available (absolute and percent changes from baseline).

Sponsors and collaborators

Lead sponsor

Pulmonx Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 13, 2019
Registry last updated
Nov 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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