An observational study in Emphysema or COPD, sponsored by Pulmonx Corporation. Completed at 12 sites in France. Per ClinicalTrials.gov, last updated 2026-02-18.
Sponsored by Pulmonx Corporation · Observational
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.
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.
331 studies on the registry are indexed under Emphysema; 60 are open to participants now.
This study's enrollment of 155 is above the median of 120 across 104 observational studies indexed under Emphysema.
Browse Emphysema studies →Pulmonx Corporation is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This is an all-comers Registry. Physicians at participating study centers will invite consecutive patients who are prescribed Zephyr Valve treatment to participate in the Registry and allow data collection.
Exclusion Criteria:
Patients undergoing the Zephyr Valve treatment for emphysema/COPD
Device: Zephyr Valve
Subjects prescribed Zephyr Valve treatment for their emphysema/COPD and treated with the Zephyr Valves.
Also known as: Zephyr System, BLVR
Forced Expiratory Volume in 1 second (FEV1)
The percent of patients achieving an improvement in the post-bronchodilator FEV1 of ≥12% at 12-months.
Time frame: 12 months
Treated Lobar Volume Reduction (TLVR)
Treated Lobar Volume Reduction (TLVR) assessed by High Resolution Computed Tomography (HRCT) at 45-days.
Time frame: 45 days
Absolute Change in Forced Expiratory Volume in 1 second FEV1 Post-Bronchodilator
Absolute Change in FEV1 from Baseline to 6-months, 12-months, 24-months and 36-months.
Time frame: Baseline, 6-months, 12-months, 24-months and 36-months
Percent Change in Forced Expiratory Volume in 1 second FEV1 Post-Bronchodilator
Percent change in FEV1 from Baseline to 6-months, 12-months, 24-months and 36-months.
Time frame: Baseline, 6-months, 12-months, 24-months and 36-months
Absolute Change in Residual Volume (RV)
Absolute Change in Residual Volume (RV) from Baseline to 6-months, 12-months, 24-months and 36-months.
Time frame: Baseline, 6-months, 12-months, 24-months and 36-months
Percent Change in Residual Volume (RV)
Percent change in Residual Volume (RV) from Baseline to 6-months, 12-months, 24-months and 36-months.
Time frame: Baseline, 6-months, 12-months, 24-months and 36-months
Absolute Change in St. George's Respiratory Questionnaire (SGRQ) Total Score
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.
Time frame: Baseline, 6-months and 12-months
Percent Change in St. George's Respiratory Questionnaire (SGRQ) Total Score
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.
Time frame: Baseline, 6-months and 12-months
Absolute Change in Modified Medical Research Council (mMRC)
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.
Time frame: Baseline, 6-months and 12-months
Percent Change in Modified Medical Research Council (mMRC)
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.
Time frame: Baseline, 6-months and 12-months
Absolute Change in Six-Minute Walk Distance (6MWT)
Absolute change in Six-Minute Walk Distance (from 6MWT) from Baseline to 6-months and 12-months.
Time frame: Baseline, 6-months and 12-months.
Percent Change in Six-Minute Walk Distance (6MWT)
Percent change in Six-Minute Walk Distance (from 6MWT) from Baseline to 6-months and 12-months.
Time frame: Baseline, 6-months and 12-months.
Plan to share: Undecided
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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