Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06332885
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-03-20
Brief Title:
Zephyr Valve Japan Post-Marketing Surveillance
Sponsor:
Pulmonx Corporation
Organization:
Pulmonx Corporation
Study Overview
Official Title:
Zephyr Valve Japan Post-Marketing Surveillance
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 localnational guidelines
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 localnational guidelines
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None