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

Pulmonx

Status: Completed

Conditions: Pulmonary Emphysema

Treatments: Device: The Pulmonx Zephyr Endobronchial Valve (EBV) 5.5- LP

Study type: Observational

Funder types: Industry

Identifiers

NCT04161235

630-0025-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

2 participants in 1 patient group

Treatment

Description:

Patients undergoing Zephyr Valve treatment with the use of at least one Zephyr Valve 5.5-LP EBV.

Treatment:

Device: The Pulmonx Zephyr Endobronchial Valve (EBV) 5.5- LP