NCT06332885

Zephyr Valve Japan Post-Marketing Surveillance

Name: Clinical Trial NCT06332885
Creator: Pulmonx Corporation
Keywords: Emphysema,COPD,Severe Emphysema, Zephyr Endobronchial Valve, device, clinical trial, Japan

Pulmonx Corporation·ClinicalTrials.gov·device·Device trialRecruiting

View on ClinicalTrials.gov →

Study focus

Disease/Condition: Emphysema,COPD,Severe Emphysema
Drug/Device/Intervention: Zephyr Endobronchial Valve
Study type: Observational
Intervention type: device

Sponsor & location

Primary sponsor: Pulmonx Corporation
Location: Gifu,Kanagawa,Kanazawa,Kawasaki,Nagasaki,Nagoya,Okayama,Osaka,Sapporo,Sendai,Shiga,Tokyo,Toyoake,Utsunomiya,Utsunomiya, Japan

Timeline & enrollment

Phase: N/A
Start date: Mar 12, 2024
End date: Mar 31, 2028
Enrollment: 140 participants

Primary outcome

Incidence rate of pneumothorax at 45-days post-Zephyr Valve index procedure.

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.

ICD-10 classifications

Emphysema, unspecifiedEmphysemaOther emphysemaInterstitial emphysemaTraumatic subcutaneous emphysema

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT06332885
Type: Device Trial

About this record

Access comprehensive clinical trial information for NCT06332885 through Pure Global AI's free database. This phase not specified trial is sponsored by Pulmonx Corporation and is currently Recruiting. The study focuses on Emphysema,COPD,Severe Emphysema. Target enrollment is 140 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.