NCT04161235

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

Post-Market Clinical Evaluation of the Zephyr Valve 5.5-LP EBV for Bronchoscopic Lung Volume Reduction (BLVR) Procedures

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2 (actual)
• Sponsor: Pulmonx Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Emphysema

Interventions

Type	Name	Description
DEVICE	The Pulmonx Zephyr Endobronchial Valve (EBV) 5.5- LP	The Zephyr Valves are implantable bronchial valves intended to control airflow in order to improve lung function in patients with hyperinflation associated with severe emphysema and/or to reduce air leaks.

Timeline

• Start date: 2020-02-05
• Primary completion: 2021-08-13
• Completion: 2021-12-30
• First posted: 2019-11-13
• Last updated: 2023-11-15

Locations

3 sites across 3 countries: Germany, Switzerland, United Kingdom

Regulatory

• FDA-regulated device study