Clinical trial NCT04161235: Post-Market Clinical Evaluation of the Zephyr Valve 5.5-LP EBV
Official title: Post-Market Clinical Evaluation of the Zephyr Valve 5.5-LP EBV for Bronchoscopic Lung Volume Reduction (BLVR) Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Emphysema
Lead sponsor: Pulmonx Corporation
Sponsor class: INDUSTRY
First posted: 2019-11-13
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population evaluated will comprise of patients with hyperinflation associated with severe emphysema that are considered appropriate for the procedure by their physician, confirmed to have little to no collateral ventilation and had at least one Zephyr Valve 5.5-LP EBV implanted during the procedure.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Treated Lobar Volume Reduction (TLVR) responders
timeFrame: 45 days
Secondary outcomes:
Other outcomes:
measure: Treated Lobar Volume Reduction (TLVR) changes from Baseline
timeFrame: 45 days
measure: Lobar occlusion
timeFrame: 45 days
measure: Post-Bronchodilator Forced Expiratory Volume in 1 second (FEV1)
timeFrame: 3 months
measure: Residual Volume (RV)
timeFrame: 3 months
measure: Total Lung Capacity
timeFrame: 3 months
measure: Inspiratory Capacity
timeFrame: 3 months
measure: Residual Volume/Total Lung Capacity (RV/TLC)
timeFrame: 3 months
measure: Inspiratory Capacity/Total Lung Capacity (IC/TLC)
timeFrame: 3 months
Locations:
city: Essen
country: Germany
facility: Ruhrlandklinik Essen - Universitätsmedizin
city: Zurich
country: Switzerland
facility: University Hospital of Zurich
city: London
country: United Kingdom
facility: Royal Brompton Hospital
Study officials:
References: