Zephyr Valve Japan Post-Marketing Surveillance
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPulmonx Corporation
About this trial
This is a multicenter, prospective, observational surveillance enrolling 140 consecutive patients with severe emphysema who are candidates for bronchoscopic lung volume reduction using Zephyr Endobronchial Valve at up to 20 centers across Japan and followed for 12 months.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Recent respiratory rehabilitation completed within the last 6 months
Not actively smoking (for at least 4 months)
TLC ≥ 100%
RV ≥ 175%
Disqualifiers
None
Trial population
The surveillance population will be adult patients (18 years or older) in Japan with hyperinflation of the lungs due to severe emphysema who are considered by their treating physician to be appropriate candidates for BLVR using Zephyr Valve and confirmed to have little to no collateral ventilation (CV-) in the target lobe. The surveillance will enroll all patients treated at the participating hospitals who provide written informed consent.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Zephyr Endobronchial Valve
DeviceZephyr Valve provides an alternative technique to achieve bronchoscopic lung volume reduction (BLVR) using a minimally invasive approach. Zephyr Valve is a tiny unidirectional valve. During BLVR, multiple valves are placed to occlude a hyperinflated lobe of the lungs, allowing air to escape while blocking airflow into the treated lobe. This is intended to result in a reduction in lung volume and hyperinflation in the targeted area. Consequently, the remaining lobes can expand more fully, the overall lung works more efficiently, with resultant improvement in overall lung function in patients with hyperinflation associated with severe emphysema.
Treatment groups
140 Participants
are divided into 1 treatment groupGroup A: Single Group Assignment1 intervention
Trial outcomes
Primary outcomes
1
Incidence rate of pneumothorax at 45-days post-Zephyr Valve index procedure.
The percentage of study subjects who experience pneumothorax within 45-days post-Zephyr Valve index procedure.
Time frame
45-days post-Zephyr Valve index procedureOther outcomes
1
Forced Expiratory Volume in 1 second (FEV1)
The volume of air in liters exhaled in the first second during forced exhalation after maximal inspiration. The MCID is a volume increase by at least 12%.
Time frame
Month 3, 6, 122
Residual Volume (RV)
The volume of air in remaining in the lungs after maximum forceful expiration. The MCID is a decrease by at least 310 mL.
Time frame
Month 3, 123
Treated lobe volume reduction (TLVR)
Treated lobe volume reduction is determined by HRCT and measured from Baseline to a given timepoint in mL and percentage of subjects achieving a ≥ 350 mL decrease
Time frame
Day 45, Month 124
Six-Minute Walk Distance (6MWD)
Measures the distance (in m) an individual is able to walk over a total of 6 minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in 6 minutes. The MCID is an increase of 6MWD by at least 26 m.
Time frame
Month 3, 6, 12Sponsors and contacts
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Source ClinicalTrials.gov