Zephyr Valve Japan Post-Marketing Surveillance

Recruiting

• Conditions: Emphysema; COPD; Severe Emphysema
• Interventions: Device: Zephyr Endobronchial Valve

• Registration Number: NCT06332885
• Lead Sponsor: Pulmonx Corporation

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 local/national guidelines.

Study Timeline

• Study Start: 2024-03-12
• Study First Submitted: 2024-03-20
• Study First Submitted QC: 2024-03-20
• Study First Posted: 2024-03-27
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-13
• Primary Completion: 2027-03-31
• Study Completion: 2028-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single Group Assignment	Zephyr Endobronchial Valve	Bronchoscopic lung volume reduction with Zephyr Valves

Primary Outcome Measures

Name	Time	Method
Incidence rate of pneumothorax at 45-days post-Zephyr Valve index procedure.	45-days post-Zephyr Valve index procedure	The percentage of study subjects who experience pneumothorax within 45-days post-Zephyr Valve index procedure.

Trial Locations

Locations (17)

Tosei General Hospital; 🇯🇵 Aichi, Japan

Matsusaka Civic Hospital; 🇯🇵 Mie, Japan

Gifu Prefectural Medical Center; 🇯🇵 Gifu, Japan

Kanagawa Cardio Chest Center; 🇯🇵 Kanagawa, Japan

Kanazawa University Hospital; 🇯🇵 Kanazawa, Japan

Nagasaki University Hospital; 🇯🇵 Nagasaki, Japan

Nagoya Medical Center; 🇯🇵 Nagoya, Japan

Okayama Medical Center; 🇯🇵 Okayama, Japan

St Marianna University Hospital; 🇯🇵 Kawasaki, Japan

Kinki Chuo Chest Medical Center; 🇯🇵 Osaka, Japan

Hokkaido University Hospital; 🇯🇵 Sapporo, Japan

Tohoku University Hospital; 🇯🇵 Sendai, Japan

Shiga University Hospital; 🇯🇵 Shiga, Japan

Tokyo National Hospital; 🇯🇵 Tokyo, Japan

Fujita Health University Hospital; 🇯🇵 Toyoake, Japan

Dokkyo University Hospital (Pulmonary Medicine and Clinical Immunology); 🇯🇵 Utsunomiya, Japan

Dokkyo University Hospital; 🇯🇵 Utsunomiya, Japan