Zephyr Valve Japan Post-Marketing Surveillance

Last updated: December 9, 2024
Sponsor: Pulmonx Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Emphysema

Treatment

Zephyr Endobronchial Valve

Clinical Study ID

NCT06332885
630-2001-01
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient is deemed eligible for BLVR using Zephyr Valve, as determined by theirtreating physician in accordance with Japanese guidelines and approved instructionfor 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

  1. Patient has little to no collateral ventilation (CV-) between the target andipsilateral lobe as confirmed by Chartis prior to undergoing BLVR.

  2. Patient is willing and able to provide informed consent to allow data collection.

Exclusion

Exclusion Criteria: None

Study Design

Total Participants: 140
Treatment Group(s): 1
Primary Treatment: Zephyr Endobronchial Valve
Phase:
Study Start date:
March 12, 2024
Estimated Completion Date:
March 31, 2028

Study 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.

Connect with a study center

  • Tosei General Hospital

    Aichi,
    Japan

    Active - Recruiting

  • Gifu Prefectural Medical Center

    Gifu,
    Japan

    Active - Recruiting

  • Kanagawa Cardio Chest Center

    Kanagawa,
    Japan

    Active - Recruiting

  • Kanazawa University Hospital

    Kanazawa,
    Japan

    Active - Recruiting

  • St Marianna University Hospital

    Kawasaki,
    Japan

    Active - Recruiting

  • Matsusaka Civic Hospital

    Mie,
    Japan

    Active - Recruiting

  • Nagasaki University Hospital

    Nagasaki,
    Japan

    Active - Recruiting

  • Nagoya Medical Center

    Nagoya,
    Japan

    Active - Recruiting

  • Okayama Medical Center

    Okayama,
    Japan

    Active - Recruiting

  • Kinki Chuo Chest Medical Center

    Osaka,
    Japan

    Active - Recruiting

  • Hokkaido University Hospital

    Sapporo,
    Japan

    Active - Recruiting

  • Tohoku University Hospital

    Sendai,
    Japan

    Active - Recruiting

  • Shiga University Hospital

    Shiga,
    Japan

    Active - Recruiting

  • Tokyo National Hospital

    Tokyo,
    Japan

    Active - Recruiting

  • Fujita Health University Hospital

    Toyoake,
    Japan

    Active - Recruiting

  • Dokkyo University Hospital

    Utsunomiya,
    Japan

    Active - Recruiting

  • Dokkyo University Hospital (Pulmonary Medicine and Clinical Immunology)

    Utsunomiya,
    Japan

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.