Zephyr Valve Japan Post-Marketing Surveillance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-12

Study Completion Date

2028-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Emphysema COPD Severe Emphysema

Keywords

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Bronchoscopic lung volume reduction Zephyr Valves

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Single Group Assignment

Bronchoscopic lung volume reduction with Zephyr Valves

Zephyr Endobronchial Valve

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ryan Melloy, MBA

Role: STUDY_DIRECTOR

Pulmonx Corporation

630-2001-01

Identifier Type: -

Identifier Source: org_study_id

Zephyr Valve Japan Post-Marketing Surveillance

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Single Group Assignment

Zephyr Endobronchial Valve

Interventions

Zephyr Endobronchial Valve

Eligibility Criteria

Inclusion Criteria

Sponsors

Pulmonx Corporation

Responsible Party

Principal Investigators

Ryan Melloy, MBA

Locations

Tosei General Hospital

Gifu Prefectural Medical Center

Kanagawa Cardio Chest Center

Kanazawa University Hospital

St Marianna University Hospital

Matsusaka Civic Hospital

Nagasaki University Hospital

Nagoya Medical Center

Okayama Medical Center

Kinki Chuo Chest Medical Center

Hokkaido University Hospital

Tohoku University Hospital

Shiga University Hospital

Tokyo National Hospital

Fujita Health University Hospital

Dokkyo University Hospital (Pulmonary Medicine and Clinical Immunology)

Dokkyo University Hospital

Countries

Central Contacts

Joshua Percy

Facility Contacts

Kensuke Kataoka, MD

Kensuke Kataoka, MD

Takahiro Masami

Fumihiro Asano, MD, PhD

Takashi Niwa, MD

Takashi Niwa, MD

Satoshi Watanabe, MD

Satoshi Watanabe, MD

Masamichi Mineshita, MD

Masamichi Mineshita, MD

Osamu Hataji, MD

Osamu Hataji, MD

Keitaro Matsumoto, MD

Keitaro Matsumoto, MD

Masahide Oki, MD

Masahide Oki, MD

Yanagihara

Ken Sato, MD

Akihiro Tamiya, MD

Akihiro Tamiya, MD

Naofumi Shinagawa, MD

Naofumi Shinagawa, MD

Hirotsugu Notsuda, MD

Hirotsugu Notsuda, MD

Yasuki Uchida, MD

Yasuki Uchida, MD

Hiroyuki Tashimo, MD

Risako Koshiyama

Kazuyoshi Imaizumi, MD

Yasuo Shimizu, MD

Yasuo Shimizu, MD

Masayuki Chida, MD

Masayuki Chida, MD

Other Identifiers

630-2001-01