Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06332885

Zephyr Valve Japan Post-Marketing Surveillance

This is a multicenter, prospective, observational surveillance enrolling 140 consecutive patients with severe emphysema who are candidates for bronchoscopic lung volume reduction using Zephyr Endobronchial Valve at up to 20 centers across Japan and followed for 12 months.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tosei General Hospital, Aichi, Japan

Loading trial locations.

About this study

This is a multicenter, prospective, observational surveillance across 20 centers in Japan enrolling 140 consecutive adult patients with hyperinflation of the lungs due to severe emphysema who are considered to be appropriate candidates for BLVR using Zephyr Endobronchial Valve (EBV, Pulmonx Corporation) and confirmed to have little to no collateral ventilation in the target lobe.

Enrolled (consented) subjects will undergo a bronchoscopy procedure with the Chartis assessment to confirm that little to no collateral ventilation is present (CV- status) followed by EBV placement in the most diseased lobe. Subject will be hospitalized for a minimum of 3 nights for observation and followed up for 12 months.

Subjects with collateral ventilation will be exited from the surveillance without treatment.

The primary endpoint is incidence rate of pneumothorax at Day 45 post-index procedure.

The effectiveness will be evaluated from Baseline to specified timepoint based on changes in lung function, exercise capacity, dyspnea and quality of life. A high-resolution computed tomography (HRCT) will be performed at Day 45 and Month 12 to determine Treated Lobe Volume Reduction (TLVR). Lung function will be assessed at Month 3, 6 and 12 by measuring post-bronchodilator forced expiratory volume in 1 second (FEV1), residual volume (RV) and 6 Minutes Walking Distance. The safety will be evaluated based on incident rate of treatment emergent adverse events through Month 12.

Subjects will be required to complete a pulmonary rehabilitation program between Day 45 and Month 3 per local/national guidelines.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient is deemed eligible for BLVR using Zephyr Valve, as determined by their treating physician in accordance with Japanese guidelines and approved instruction for use. These include:
  • Recent respiratory rehabilitation completed within the last 6 months
  • Not actively smoking (for at least 4 months)
  • TLC ≥ 100%
  • RV ≥ 175%
  • FEV1 15-45% post-bronchodilator
  • 6MWD 100-500 m
  • mMRC score ≥ 2
  • No coagulation disorder
  • No evidence of active respiratory infection
  • Patient has little to no collateral ventilation (CV-) between the target and ipsilateral lobe as confirmed by Chartis prior to undergoing BLVR.
  • Patient is willing and able to provide informed consent to allow data collection.

Exclusion criteria

None

Treatment and study plan

Zephyr Endobronchial Valve

Device

Zephyr Valve provides an alternative technique to achieve bronchoscopic lung volume reduction (BLVR) using a minimally invasive approach. Zephyr Valve is a tiny unidirectional valve. During BLVR, multiple valves are placed to occlude a hyperinflated lobe of the lungs, allowing air to escape while blocking airflow into the treated lobe. This is intended to result in a reduction in lung volume and hyperinflation in the targeted area. Consequently, the remaining lobes can expand more fully, the overall lung works more efficiently, with resultant improvement in overall lung function in patients with hyperinflation associated with severe emphysema.

Primary outcomes

  1. Incidence rate of pneumothorax at 45-days post-Zephyr Valve index procedure.

    Time frame: 45-days post-Zephyr Valve index procedure

    The percentage of study subjects who experience pneumothorax within 45-days post-Zephyr Valve index procedure.

Other outcomes

  1. Forced Expiratory Volume in 1 second (FEV1)

    Time frame: Month 3, 6, 12

    The volume of air in liters exhaled in the first second during forced exhalation after maximal inspiration. The MCID is a volume increase by at least 12%.

  2. Residual Volume (RV)

    Time frame: Month 3, 12

    The volume of air in remaining in the lungs after maximum forceful expiration. The MCID is a decrease by at least 310 mL.

  3. Treated lobe volume reduction (TLVR)

    Time frame: Day 45, Month 12

    Treated lobe volume reduction is determined by HRCT and measured from Baseline to a given timepoint in mL and percentage of subjects achieving a ≥ 350 mL decrease

  4. Six-Minute Walk Distance (6MWD)

    Time frame: Month 3, 6, 12

    Measures the distance (in m) an individual is able to walk over a total of 6 minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in 6 minutes. The MCID is an increase of 6MWD by at least 26 m.

  5. Modified Medical Research Council Dyspnea (mMRC) Scale score

    Time frame: Month 3, 6, 12

    A self-rating tool to measure the degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4 as follows:

    • 0: Dyspnea only with strenuous exercise
    • 1: Dyspnea when hurrying or walking up a slight hill
    • 2: Walks slower than people of same age because of dyspnea or has to stop for breath when walking at own pace
    • 3: Stops for breath after walking 100 yards (91 m) or after a few minutes
    • 4: Too dyspneic to leave house or breathless when dressing The MCID is a total score reduction by at least 1 point.

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

    Time frame: Month 3, 6, 12

    A validated, disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Total score for 3 component domains (impact, activity, symptoms) ranges from 0 to 100. Higher score indicates worse quality of life. The MCID is a decrease by at least 4 points.

Study contacts

Contact information is provided by the study sponsor or research team.

Joshua Percy

CONTACT

[email protected]

+1 650-810-1420

Sponsors and collaborators

Lead sponsor

Pulmonx Corporation

Industry

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Mar 27, 2024
Registry last updated
Dec 13, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.