Zephyr Valve Registry (ZEVR)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    150
  • sponsor
    Pulmonx Corporation
Updated on 15 September 2022
bronchoscopy
zephyr

Summary

The purpose of this Post-Approval Registry is to gather ongoing safety and effectiveness assessment of the Zephyr Valve treatment in a real-world setting.

Description

The Zephyr Valve Registry (ZEVR) is a multi-center, single-arm, prospective Registry. The objective of this Registry is to provide ongoing safety and effectiveness assessment of the Zephyr Valve treatment of patients with hyperinflation associated with severe emphysema, in regions of the lung that have little to no collateral ventilation.

Approximately 150 patients undergoing Zephyr Valve treatment in the commercial setting will be enrolled and followed out to 3 years. Assessments will be conducted at 45-days, 6-months, 12-months, 24-months and 36-months post-procedure. The Zephyr Valve Registry will be conducted at a minimum of 5, and a maximum of 10 clinical sites.

Subjects prescribed Zephyr Valve treatment for their emphysema will be consented and will be enrolled only after determination of little to no collateral ventilation between target and ipsilateral lobes. Safety and effectiveness of the Zephyr Valve treatment will be evaluated post-treatment based on data collected out to 3 years after the treatment.

Details
Condition Emphysema
Treatment Zephyr Valve Procedure
Clinical Study IdentifierNCT04186546
SponsorPulmonx Corporation
Last Modified on15 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects with severe emphysema considered appropriate for the procedure by the physician
Subjects who signed an Informed Consent Form to allow data collection

Exclusion Criteria

• Subjects determined to have collateral ventilation between the target(s) and ipsilateral
lobe(s)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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