Zephyr Valve Japan Post-Marketing Surveillance
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Zephyr Endobronchial Valve.
- Who it may be relevant to
- Registry conditions: Emphysema, COPD, Severe Emphysema. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
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.
Interventions
- 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 ove
Primary outcome measures
- Incidence rate of pneumothorax at 45-days post-Zephyr Valve index procedure. [Time frame: 45-days post-Zephyr Valve index procedure]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Japan · 17 centers
- Tosei General Hospital — Aichi
- Gifu Prefectural Medical Center — Gifu
- Kanagawa Cardio Chest Center — Kanagawa
- Kanazawa University Hospital — Kanazawa
- St Marianna University Hospital — Kawasaki
- Matsusaka Civic Hospital — Mie
- Nagasaki University Hospital — Nagasaki
- Nagoya Medical Center — Nagoya
- … and 9 more centers
Identifiers
NCT: NCT06332885 · 630-2001-01