Zephyr Valve Japan Post-Marketing Surveillance

Launched by PULMONX CORPORATION · Mar 20, 2024

Keywords

ClinConnect Summary

The Zephyr Valve Japan Post-Marketing Surveillance trial is studying the safety and effectiveness of a treatment called the Zephyr Endobronchial Valve for patients with severe emphysema. This trial aims to enroll 140 patients across 20 medical centers in Japan who have been diagnosed with emphysema and are considering this specific treatment. Participants will be followed for 12 months to monitor their health and improvements in breathing.

To be eligible for this trial, patients should be between the ages of 65 and 74 and must meet certain health criteria. For example, they should have recently completed a respiratory rehabilitation program, not be actively smoking, and have specific lung function measurements. If you or someone you know is interested in participating, it’s important to discuss it with a doctor who can determine if this trial is a good fit. Participants can expect to contribute to valuable research while receiving close medical supervision throughout the study period.

Gender

ALL

Eligibility 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