Post-Market Clinical Evaluation of the Zephyr Valve 5.5-LP EBV

Completed

• Conditions: Pulmonary Emphysema
• Interventions: Device: The Pulmonx Zephyr Endobronchial Valve (EBV) 5.5- LP

• Registration Number: NCT04161235
• Lead Sponsor: Pulmonx Corporation

Brief Summary

This is a Post-Market Evaluation of the Zephyr Valve 5.5-LP EBV to assess Treated Lobar Volume Reduction (TLVR), changes in lung function and the safety profile of the Zephyr Valve treatment with the use of at least one Zephyr Valve 5.5-LP EBV.

Detailed Description

This is a multi-center, single-arm, prospective, observational study. Approximately 70 study participants undergoing Zephyr Valve treatment with the use of at least one Zephyr Valve 5.5-LP EBV will be enrolled and followed out to 3 months. Assessments will be conducted at 45 days and 3 months. The evaluation will be conducted at up to 6 sites.

Patients prescribed Zephyr Valve treatment for their emphysema will be consented and will be enrolled only after: 1) determination of little to no collateral ventilation between target and ipsilateral lobes and 2) implantation of at least one Zephyr Valve 5.5-LP EBV. Baseline data will be collected retrospectively after enrollment of a patient in the Post-Market Evaluation. Performance and safety of the Zephyr Valve treatment with the use of at least one Zephyr Valve 5.5-LP will be evaluated post-treatment based on data collected until 3 months after the treatment.

Study Timeline

• Study First Submitted: 2019-11-08
• Study First Submitted QC: 2019-11-08
• Study First Posted: 2019-11-13
• Study Start: 2020-02-05
• Primary Completion: 2021-08-13
• Study Completion: 2021-12-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• Patients with severe emphysema prescribed treatment with Zephyr Valves
• Zephyr Valve Treatment with the use of at least one Zephyr Valve 5.5-LP EBV

Exclusion Criteria

• Patients determined to have collateral ventilation between the target(s) and ipsilateral lobe(s).
• Patients who undergo Zephyr Valve treatment, but no Zephyr Valve 5.5-LP EBV implanted.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment	The Pulmonx Zephyr Endobronchial Valve (EBV) 5.5- LP	Patients undergoing Zephyr Valve treatment with the use of at least one Zephyr Valve 5.5-LP EBV.

Primary Outcome Measures

Name	Time	Method
Treated Lobar Volume Reduction (TLVR) responders	45 days	The percentage of patients treated with the Zephyr Valve 5.5-LP EBV who achieved a Treated Lobar Volume Reduction (TLVR) of the treated lobe (s) of ≥350ml as seen via HRCT at 45-days.

Trial Locations

Locations (3)

Ruhrlandklinik Essen - Universitätsmedizin; 🇩🇪 Essen, Germany

University Hospital of Zurich; 🇨🇭 Zurich, Switzerland

Royal Brompton Hospital; 🇬🇧 London, United Kingdom