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Zephyr Valve Japan Post-Marketing Surveillance

NCT06332885 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 140

Last updated 2024-12-13

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Pulmonx Corporation

    lead INDUSTRY

Principal Investigators

  • Ryan Melloy, MBA · Pulmonx Corporation

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-12
Primary Completion
2027-03-31
Completion
2028-03-31
FDA Device
Yes

Countries

  • Japan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06332885 on ClinicalTrials.gov