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NCT Number: NCT04517916

Zephyr Etude Post-Inscription (French Registry)

The objective of this Registry is to provide ongoing safety and effectiveness assessment of the Zephyr Valve treatment of adult patients with Chronic Obstructive Pulmonary Disease (COPD) Grade III and Grade IV in order to support the renewal of the inscription of the Zephyr Valve on the list LPPR (Art 165-1) in France.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital La Cavale Blanche, Brest, France

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About this study

This is a multi-center, single-arm, prospective Registry to be conducted at a minimum of 12 study centers. Approximately 150 patients with severe emphysema undergoing Zephyr Valve treatment will be enrolled and followed out to 3 years. Assessments will be performed at 45-days, 6-months, 12-months, 24-months and 36-months post-procedure.

Patients prescribed the Zephyr Valve treatment will be consented and will be enrolled only after determination of little to no collateral ventilation between target and ipsilateral lobes. Safety and effectiveness of the Zephyr Valve treatment will be evaluated post-treatment based on data collected out to 3-years post-treatment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with emphysema (COPD Grade III and Grade IV) considered appropriate for the bronchoscopic lung volume reduction 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).

Treatment and study plan

Zephyr Valve

Device

Subjects prescribed Zephyr Valve treatment for their emphysema/COPD and treated with the Zephyr Valves.

Other names: Zephyr System, BLVR

Primary outcomes

  1. Forced Expiratory Volume in 1 second (FEV1)

    Time frame: 12 months

    The percent of patients achieving an improvement in the post-bronchodilator FEV1 of ≥12% at 12-months.

Secondary outcomes

  1. Treated Lobar Volume Reduction (TLVR)

    Time frame: 45 days

    Treated Lobar Volume Reduction (TLVR) assessed by High Resolution Computed Tomography (HRCT) at 45-days.

Other outcomes

  1. Absolute Change in Forced Expiratory Volume in 1 second FEV1 Post-Bronchodilator

    Time frame: Baseline, 6-months, 12-months, 24-months and 36-months

    Absolute Change in FEV1 from Baseline to 6-months, 12-months, 24-months and 36-months.

  2. Percent Change in Forced Expiratory Volume in 1 second FEV1 Post-Bronchodilator

    Time frame: Baseline, 6-months, 12-months, 24-months and 36-months

    Percent change in FEV1 from Baseline to 6-months, 12-months, 24-months and 36-months.

  3. Absolute Change in Residual Volume (RV)

    Time frame: Baseline, 6-months, 12-months, 24-months and 36-months

    Absolute Change in Residual Volume (RV) from Baseline to 6-months, 12-months, 24-months and 36-months.

  4. Percent Change in Residual Volume (RV)

    Time frame: Baseline, 6-months, 12-months, 24-months and 36-months

    Percent change in Residual Volume (RV) from Baseline to 6-months, 12-months, 24-months and 36-months.

  5. Absolute Change in St. George's Respiratory Questionnaire (SGRQ) Total Score

    Time frame: Baseline, 6-months and 12-months

    Absolute change in St. George's Respiratory Questionnaire (SGRQ) from Baseline to 6-months and 12-months.

    The St. George's Respiratory Questionnaire measures health status (quality of life) in patients with diseases of airways obstruction. Scores range from 0 to 100, with higher scores indicating more limitations.

  6. Percent Change in St. George's Respiratory Questionnaire (SGRQ) Total Score

    Time frame: Baseline, 6-months and 12-months

    Percent change in St. George's Respiratory Questionnaire (SGRQ) Total Score from Baseline to 6-months and 12-months.

    The St. George's Respiratory Questionnaire measures health status (quality of life) in patients with diseases of airways obstruction. Scores range from 0 to 100, with higher scores indicating more limitations.

  7. Absolute Change in Modified Medical Research Council (mMRC)

    Time frame: Baseline, 6-months and 12-months

    Absolute Change in the Modified Medical Research Council (mMRC) Dyspnea Scale from Baseline to 6-months and 12-months.

    The mMRC (Modified Medical Research Council) stratifies severity of dyspnea in respiratory diseases. The severity of dyspnea is rated on a scale of 0 to 4, with higher scores indicating more limitations.

  8. Percent Change in Modified Medical Research Council (mMRC)

    Time frame: Baseline, 6-months and 12-months

    Percent change in the Modified Medical Research Council (mMRC) Dyspnea Scale from Baseline to 6-months and 12-months.

    The mMRC (Modified Medical Research Council) stratifies severity of dyspnea in respiratory diseases. The severity of dyspnea is rated on a scale of 0 to 4, with higher scores indicating more limitations.

  9. Absolute Change in Six-Minute Walk Distance (6MWT)

    Time frame: Baseline, 6-months and 12-months.

    Absolute change in Six-Minute Walk Distance (from 6MWT) from Baseline to 6-months and 12-months.

  10. Percent Change in Six-Minute Walk Distance (6MWT)

    Time frame: Baseline, 6-months and 12-months.

    Percent change in Six-Minute Walk Distance (from 6MWT) from Baseline to 6-months and 12-months.

Sponsors and collaborators

Lead sponsor

Pulmonx Corporation

Industry

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2026
First posted
Aug 19, 2020
Registry last updated
Feb 18, 2026

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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