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Endobronchial Silicone Valve for Patients With Emphysema

StatusRecruiting
PhaseNot applicable
Started2025-07-08
View on ClinicalTrials.gov ↗

Amendment history

2026-07-06
Not Yet Recruiting→Recruiting Study Status, Study Description, Arms and Interventions, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-07→confirmed 2025-07-08
InterventionsEBV (Device), ESV (Device)→ESV (Device), Optimal Medical Management (OMM) (Other)
Study description+96 characters
[...] h optimal medical therapy. The 'Control' group will receive Zephyr Endobronchial Valve (EBV) in combination with optimal medical therapy alone. For every three participants in the study, two will go int [...] 'Treatment' group and one will go into the 'Control' group. For every three participants in the study, two will go into the 'Treatment' group and one will go into the 'Control' group. It is hypothesized that the ESVafter hasplacement similarof efficacythe andEBV, safetylung function will be improved as compared to EBVstandard inmedical treatingtherapy patients with severe emphysemaalone.
Study sitesdetails revised at 1 of 1 site
2025-07-30
Original filing
The purpose of this research is to evaluate the efficacy and safety of endobronchial silicone valve in patients with severe emphysema.
Trial Details
NCT Number NCT07097896
Lead Sponsor China-Japan Friendship Hospital
Collaborators: Beijing Cardiotech Medical Technology CO., LTD
Conditions Emphysema
Enrollment 147 participants
Start Date 2025-07-08
Primary Completion 2027-07 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2026-07-08