Zephyr Etude Post-Inscription (French Registry)
Status
Conditions
Treatments
Details and patient eligibility
About
The objective of this Registry is to provide ongoing safety and effectiveness assessment of the Zephyr Valve treatment of adult patients with Chronic Obstructive Pulmonary Disease (COPD) Grade III and Grade IV in order to support the renewal of the inscription of the Zephyr Valve on the list LPPR (Art 165-1) in France.
Full description
This is a multi-center, single-arm, prospective Registry to be conducted at a minimum of 12 study centers. Approximately 150 patients with severe emphysema undergoing Zephyr Valve treatment will be enrolled and followed out to 3 years. Assessments will be performed at 45-days, 6-months, 12-months, 24-months and 36-months post-procedure.
Patients prescribed the Zephyr Valve treatment 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 post-treatment.
Enrollment
Sex
Volunteers
Inclusion criteria
- Patients with emphysema (COPD Grade III and Grade IV) considered appropriate for the bronchoscopic lung volume reduction 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).
Trial design
155 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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