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

Pulmonary Emphysema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04161235
• Other study ID #: 630-0025-01
• Status: Completed
• Start date: February 5, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: November 2023
• Source: Pulmonx Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: December 30, 2021
• Est. primary completion date: August 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Emphysema
• Pulmonary Emphysema

Intervention

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.

Locations

Country	Name	City	State
Germany	Ruhrlandklinik Essen - Universitätsmedizin	Essen
Switzerland	University Hospital of Zurich	Zurich
United Kingdom	Royal Brompton Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Pulmonx Corporation

Countries where clinical trial is conducted

Germany,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treated Lobar Volume Reduction (TLVR) changes from Baseline	Treated Lobar Volume Reduction (TLVR) as seen via HRCT at 45-days (absolute and percent changes from baseline).	45 days
Other	Lobar occlusion	Lobar occlusion of the treated lobe at 45-days post-procedure as visualized by HRCT.	45 days
Other	Post-Bronchodilator Forced Expiratory Volume in 1 second (FEV1)	Post-Bronchodilator Forced Expiratory Volume in 1 second (FEV1) at 3-months (absolute and percent changes from baseline).	3 months
Other	Residual Volume (RV)	Residual Volume at 3 months, when available (absolute and percent changes from baseline).	3 months
Other	Total Lung Capacity	Total Lung Capacity (TLC) at 3 months, when available (absolute and percent changes from baseline).	3 months
Other	Inspiratory Capacity	Inspiratory Capacity (IC) at 3 months, when available (absolute and percent changes from baseline).	3 months
Other	Residual Volume/Total Lung Capacity (RV/TLC)	RV/TLC ratio at 3 months, when available (absolute and percent changes from baseline).	3 months
Other	Inspiratory Capacity/Total Lung Capacity (IC/TLC)	IC/TLC ratio at 3 months, when available (absolute and percent changes from baseline).	3 months
Primary	Treated Lobar Volume Reduction (TLVR) responders	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.	45 days