Zephyr Valve Japan Post-Marketing Surveillance

NCT06332885 | Recruiting DMC FDA Device

• 1 other identifier: 630-2001-01
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 17

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.

Conditions

Emphysema; COPD; Severe Emphysema

Keywords

Bronchoscopic lung volume reduction; Zephyr Valves

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (6)

• Forced Expiratory Volume in 1 second (FEV1)

  Month 3, 6, 12

• Residual Volume (RV)

  Month 3, 12

• Treated lobe volume reduction (TLVR)

  Day 45, Month 12

Study Arms (1)

Single Group Assignment

Bronchoscopic lung volume reduction with Zephyr Valves

Device: Zephyr Endobronchial Valve

Interventions

Zephyr Endobronchial Valve DEVICE

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.

Single Group Assignment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• MWD 100-500 m
• mMRC score ≥ 2
• No coagulation disorder
• No evidence of active respiratory infection
• Patient has little to no collateral ventilation (CV-) between the target and ipsilateral lobe as confirmed by Chartis prior to undergoing BLVR.
• Patient is willing and able to provide informed consent to allow data collection.

Sponsors & Collaborators

• Pulmonx Corporation: lead

Study Sites (17)

Tosei General Hospital

Aichi, Japan

RECRUITING

Gifu Prefectural Medical Center

Gifu, Japan

RECRUITING

Kanagawa Cardio Chest Center

Kanagawa, Japan

RECRUITING

Kanazawa University Hospital

Kanazawa, Japan

RECRUITING

St Marianna University Hospital

Kawasaki, Japan

RECRUITING

Matsusaka Civic Hospital

Mie, Japan

RECRUITING

Nagasaki University Hospital

Nagasaki, Japan

RECRUITING

Nagoya Medical Center

Nagoya, Japan

RECRUITING

Okayama Medical Center

Okayama, Japan

RECRUITING

Kinki Chuo Chest Medical Center

Osaka, Japan

RECRUITING

Hokkaido University Hospital

Sapporo, Japan

RECRUITING

Tohoku University Hospital

Sendai, Japan

RECRUITING

Shiga University Hospital

Shiga, Japan

RECRUITING

Tokyo National Hospital

Tokyo, Japan

RECRUITING

Fujita Health University Hospital

Toyoake, Japan

RECRUITING

Dokkyo University Hospital (Pulmonary Medicine and Clinical Immunology)

Utsunomiya, Japan

NOT YET RECRUITING

Dokkyo University Hospital

Utsunomiya, Japan

RECRUITING

MeSH Terms

Conditions

Emphysema; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes

Study Officials

• Ryan Melloy, MBA

  Pulmonx Corporation

  STUDY DIRECTOR

Central Study Contacts

Joshua Percy

CONTACT

+1 650-810-1420; jpercy@pulmonx.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: March 27, 2024
• Study Start: March 12, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

JP (17)