Zephyr Valve Japan Post-Marketing Surveillance

COPD Clinical Trial

Official title:

Zephyr Valve Japan Post-Marketing Surveillance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06332885
• Other study ID #: 630-2001-01
• Status: Recruiting
• Start date: March 12, 2024
• Est. completion date: March 31, 2028

Study information

• Verified date: April 2024
• Source: Pulmonx Corporation
• Contact: Joshua Percy
• Phone: +1 650-810-1420
• Email: jpercy[@]pulmonx.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: March 31, 2028
• Est. primary completion date: March 31, 2027
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Emphysema
• Pulmonary Emphysema
• Severe Emphysema

Intervention

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 overall lung works more efficiently, with resultant improvement in overall lung function in patients with hyperinflation associated with severe emphysema.

Locations

Country	Name	City	State
Japan	Gifu Prefectural Medical Center	Gifu
Japan	Kanagawa Cardio Chest Center	Kanagawa
Japan	Kanazawa University Hospital	Kanazawa
Japan	St Marianna University Hospital	Kawasaki
Japan	Nagasaki University Hospital	Nagasaki
Japan	Nagoya Medical Center	Nagoya
Japan	Okayama Medical Center	Okayama
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	Utsunomiya
Japan	Dokkyo University Hospital (Pulmonary Medicine and Clinical Immunology)	Utsunomiya

Sponsors (1)

Lead Sponsor	Collaborator
Pulmonx Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Forced Expiratory Volume in 1 second (FEV1)	The volume of air in liters exhaled in the first second during forced exhalation after maximal inspiration. The MCID is a volume increase by at least 12%.	Month 3, 6, 12
Other	Residual Volume (RV)	The volume of air in remaining in the lungs after maximum forceful expiration. The MCID is a decrease by at least 310 mL.	Month 3, 12
Other	Treated lobe volume reduction (TLVR)	Treated lobe volume reduction is determined by HRCT and measured from Baseline to a given timepoint in mL and percentage of subjects achieving a = 350 mL decrease	Day 45, Month 12
Other	Six-Minute Walk Distance (6MWD)	Measures the distance (in m) an individual is able to walk over a total of 6 minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in 6 minutes. The MCID is an increase of 6MWD by at least 26 m.	Month 3, 6, 12
Other	Modified Medical Research Council Dyspnea (mMRC) Scale score	A self-rating tool to measure the degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4 as follows: 0: Dyspnea only with strenuous exercise; 1: Dyspnea when hurrying or walking up a slight hill; 2: Walks slower than people of same age because of dyspnea or has to stop for breath when walking at own pace; 3: Stops for breath after walking 100 yards (91 m) or after a few minutes; 4: Too dyspneic to leave house or breathless when dressing The MCID is a total score reduction by at least 1 point.	Month 3, 6, 12
Other	St. George's Respiratory Questionnaire (SGRQ) Total Score	A validated, disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Total score for 3 component domains (impact, activity, symptoms) ranges from 0 to 100. Higher score indicates worse quality of life. The MCID is a decrease by at least 4 points.	Month 3, 6, 12
Primary	Incidence rate of pneumothorax at 45-days post-Zephyr Valve index procedure.	The percentage of study subjects who experience pneumothorax within 45-days post-Zephyr Valve index procedure.	45-days post-Zephyr Valve index procedure