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NCT06332885 | RECRUITING | Emphysema

Zephyr Valve Japan Post-Marketing Surveillance
Sponsor:

Pulmonx Corporation

Brief Summary:

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.

Condition or disease

Emphysema

COPD

Severe Emphysema

Intervention/treatment

Zephyr Endobronchial Valve

Detailed Description:

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 140 participants
Official Title : Zephyr Valve Japan Post-Marketing Surveillance
Actual Study Start Date : 2024-03-12
Estimated Primary Completion Date : 2027-03-31
Estimated Study Completion Date : 2028-03-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. 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
    • 2. Patient has little to no collateral ventilation (CV-) between the target and ipsilateral lobe as confirmed by Chartis prior to undergoing BLVR.
    • 3. Patient is willing and able to provide informed consent to allow data collection.
    Exclusion Criteria: None
Zephyr Valve Japan Post-Marketing Surveillance

Location Details

NCT06332885

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Japan,

Tosei General Hospital

Aichi, Japan,

RECRUITING

Japan,

Gifu Prefectural Medical Center

Liver, Japan,

RECRUITING

Japan,

Kanagawa Cardio Chest Center

Kanagawa, Japan,

RECRUITING

Japan,

Kanazawa University Hospital

Kanazawa, Japan,

RECRUITING

Japan,

St Marianna University Hospital

Kawasaki, Japan,

RECRUITING

Japan,

Matsusaka Civic Hospital

Mie, Japan,

RECRUITING

Japan,

Nagasaki University Hospital

Nagasaki, Japan,

RECRUITING

Japan,

Nagoya Medical Center

Nagoya, Japan,

RECRUITING

Japan,

Okayama Medical Center

Okayama, Japan,

RECRUITING

Japan,

Kinki Chuo Chest Medical Center

Osaka, Japan,

RECRUITING

Japan,

Hokkaido University Hospital

Sapporo, Japan,

RECRUITING

Japan,

Tohoku University Hospital

Sendai, Japan,

RECRUITING

Japan,

Shiga University Hospital

Enter, Japan,

RECRUITING

Japan,

Tokyo National Hospital

Tokyo, Japan,

RECRUITING

Japan,

Fujita Health University Hospital

Toyoake, Japan,

NOT YET RECRUITING

Japan,

Dokkyo University Hospital (Pulmonary Medicine and Clinical Immunology)

Utsunomiya, Japan,

RECRUITING

Japan,

Dokkyo University Hospital

Utsunomiya, Japan,