Zephyr Valve Japan Post-Marketing Surveillance

April 17, 2024 updated by: Pulmonx Corporation
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
      • Gifu, Japan
        • Recruiting
        • Gifu Prefectural Medical Center
        • Contact:
        • Principal Investigator:
          • Fumihiro Asano, MD, PhD
      • Kanagawa, Japan
        • Recruiting
        • Kanagawa Cardio Chest Center
        • Contact:
        • Principal Investigator:
          • Takashi Niwa, MD
      • Kanazawa, Japan
      • Kawasaki, Japan
        • Recruiting
        • St Marianna University Hospital
        • Contact:
        • Principal Investigator:
          • Masamichi Mineshita, MD
      • Nagasaki, Japan
        • Recruiting
        • Nagasaki University Hospital
        • Contact:
        • Principal Investigator:
          • Keitaro Matsumoto, MD
      • Nagoya, Japan
        • Recruiting
        • Nagoya Medical Center
        • Contact:
        • Principal Investigator:
          • Masahide Oki, MD
      • Okayama, Japan
        • Recruiting
        • Okayama Medical Center
        • Contact:
        • Principal Investigator:
          • Ken Sato, MD
      • Osaka, Japan
      • Sapporo, Japan
        • Recruiting
        • Hokkaido University Hospital
        • Contact:
        • Principal Investigator:
          • Naofumi Shinagawa, MD
      • Sendai, Japan
      • Shiga, Japan
        • Recruiting
        • Shiga University Hospital
        • Contact:
        • Principal Investigator:
          • Yasuki Uchida, MD
      • Tokyo, Japan
        • Recruiting
        • Tokyo National Hospital
        • Contact:
          • Hiroyuki Tashimo, MD
        • Principal Investigator:
          • Hiroyuki Tashimo, MD
      • Toyoake, Japan
        • Recruiting
        • Fujita Health University Hospital
        • Contact:
        • Principal Investigator:
          • Kazuyoshi Imaizumi, MD
      • Utsunomiya, Japan
        • Recruiting
        • Dokkyo University Hospital
        • Contact:
        • Principal Investigator:
          • Masayuki Chida, MD
      • Utsunomiya, Japan
        • Not yet recruiting
        • Dokkyo University Hospital (Pulmonary Medicine and Clinical Immunology)
        • Contact:
        • Principal Investigator:
          • Yasuo Shimizu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The surveillance population will be adult patients (18 years or older) in Japan with hyperinflation of the lungs due to severe emphysema who are considered by their treating physician to be appropriate candidates for BLVR using Zephyr Valve and confirmed to have little to no collateral ventilation (CV-) in the target lobe. The surveillance will enroll all patients treated at the participating hospitals who provide written informed consent.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Single Group Assignment
Bronchoscopic lung volume reduction with Zephyr Valves
Device: Zephyr Endobronchial Valve
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
45-days post-Zephyr Valve index procedure

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%.
Month 3, 6, 12
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.
Month 3, 12
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
Day 45, Month 12
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.
Month 3, 6, 12
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.
Month 3, 6, 12
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.
Month 3, 6, 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pulmonx Corporation

Investigators

  • Study Director: Anna Gawlicka, PhD, MBA, Pulmonx Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2024

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

March 20, 2024

First Submitted That Met QC Criteria

March 20, 2024

First Posted (Actual)

March 27, 2024

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 630-2001-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All data will be aggregated and analyzed. No IPD will be made available for sharing to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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