Clinical trial NCT06332885: Zephyr Valve Japan Post-Marketing Surveillance
Official title: Zephyr Valve Japan Post-Marketing Surveillance
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Emphysema
COPD
Severe Emphysema
Keywords: Bronchoscopic lung volume reduction
Zephyr Valves
Lead sponsor: Pulmonx Corporation
Sponsor class: INDUSTRY
First posted: 2024-03-27
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The surveillance population will be adult patients (18 years or older) in Japan with hyperinflation of the lungs due to severe emphysema who are considered by their treating physician to be appropriate candidates for BLVR using Zephyr Valve and confirmed to have little to no collateral ventilation (CV-) in the target lobe. The surveillance will enroll all patients treated at the participating hospitals who provide written informed consent.

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.

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

Primary outcomes:
measure: Incidence rate of pneumothorax at 45-days post-Zephyr Valve index procedure.
timeFrame: 45-days post-Zephyr Valve index procedure
Secondary outcomes:
Other outcomes:
measure: Forced Expiratory Volume in 1 second (FEV1)
timeFrame: Month 3, 6, 12
measure: Residual Volume (RV)
timeFrame: Month 3, 12
measure: Treated lobe volume reduction (TLVR)
timeFrame: Day 45, Month 12
measure: Six-Minute Walk Distance (6MWD)
timeFrame: Month 3, 6, 12
measure: Modified Medical Research Council Dyspnea (mMRC) Scale score
timeFrame: Month 3, 6, 12
measure: St. George's Respiratory Questionnaire (SGRQ) Total Score
timeFrame: Month 3, 6, 12
Locations:
city: Aichi
country: Japan
facility: Tosei General Hospital
city: Gifu
country: Japan
facility: Gifu Prefectural Medical Center
city: Kanagawa
country: Japan
facility: Kanagawa Cardio Chest Center
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
city: Kawasaki
country: Japan
facility: St Marianna University Hospital
city: Mie
country: Japan
facility: Matsusaka Civic Hospital
city: Nagasaki
country: Japan
facility: Nagasaki University Hospital
city: Nagoya
country: Japan
facility: Nagoya Medical Center
city: Okayama
country: Japan
facility: Okayama Medical Center
city: Osaka
country: Japan
facility: Kinki Chuo Chest Medical Center
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
city: Sendai
country: Japan
facility: Tohoku University Hospital
city: Shiga
country: Japan
facility: Shiga University Hospital
city: Tokyo
country: Japan
facility: Tokyo National Hospital
city: Toyoake
country: Japan
facility: Fujita Health University Hospital
city: Utsunomiya
country: Japan
facility: Dokkyo University Hospital (Pulmonary Medicine and Clinical Immunology)
city: Utsunomiya
country: Japan
facility: Dokkyo University Hospital
Study officials:
affiliation: Pulmonx Corporation
name: Ryan Melloy, MBA
role: STUDY_DIRECTOR
References: