Pulmonary Emphysema
Conditions
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.
Interventions
DEVICEThe 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.
Sponsors
Pulmonx Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Lobar occlusion | 45 days | Lobar occlusion of the treated lobe at 45-days post-procedure as visualized by HRCT. |
| Post-Bronchodilator Forced Expiratory Volume in 1 second (FEV1) | 3 months | Post-Bronchodilator Forced Expiratory Volume in 1 second (FEV1) at 3-months (absolute and percent changes from baseline). |
| Residual Volume (RV) | 3 months | Residual Volume at 3 months, when available (absolute and percent changes from baseline). |
| Treated Lobar Volume Reduction (TLVR) changes from Baseline | 45 days | Treated Lobar Volume Reduction (TLVR) as seen via HRCT at 45-days (absolute and percent changes from baseline). |
| Inspiratory Capacity | 3 months | Inspiratory Capacity (IC) at 3 months, when available (absolute and percent changes from baseline). |
| Residual Volume/Total Lung Capacity (RV/TLC) | 3 months | RV/TLC ratio at 3 months, when available (absolute and percent changes from baseline). |
| Inspiratory Capacity/Total Lung Capacity (IC/TLC) | 3 months | IC/TLC ratio at 3 months, when available (absolute and percent changes from baseline). |
| Total Lung Capacity | 3 months | Total Lung Capacity (TLC) at 3 months, when available (absolute and percent changes from baseline). |
Countries
Germany, Switzerland, United Kingdom
Outcome results
None listed