Zephyr Valve Japan Post-Marketing Surveillance

Recruiting now

Conditions studied: Emphysema, COPD, Severe Emphysema

In brief

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.

Key facts

Study ID

NCT06332885

Run by

Pulmonx Corporation

People needed

140

Starts

2024-03-12

Expected to finish

2028-03-31

Last updated by the study team

2024-12-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is deemed eligible for BLVR using Zephyr Valve, as determined by their treating physician in accordance with Japanese guidelines and approved instruction for use. These include:
• Recent respiratory rehabilitation completed within the last 6 months
• Not actively smoking (for at least 4 months)
• TLC ≥ 100%
• RV ≥ 175%
• FEV1 15-45% post-bronchodilator
• 6MWD 100-500 m
• mMRC score ≥ 2
• No coagulation disorder
• No evidence of active respiratory infection
• Patient has little to no collateral ventilation (CV-) between the target and ipsilateral lobe as confirmed by Chartis prior to undergoing BLVR.
• Patient is willing and able to provide informed consent to allow data collection.
• Exclusion Criteria: None

Where it is running

• Dokkyo University Hospital — Utsunomiya, Japan (enrolling)
• Gifu Prefectural Medical Center — Gifu, Japan (enrolling)
• Kanagawa Cardio Chest Center — Kanagawa, Japan (enrolling)
• Kanazawa University Hospital — Kanazawa, Japan (enrolling)
• St Marianna University Hospital — Kawasaki, Japan (enrolling)
• Matsusaka Civic Hospital — Mie, Japan (enrolling)
• Nagasaki University Hospital — Nagasaki, Japan (enrolling)
• Nagoya Medical Center — Nagoya, Japan (enrolling)
• Okayama Medical Center — Okayama, Japan (enrolling)
• Kinki Chuo Chest Medical Center — Osaka, Japan (enrolling)
• Hokkaido University Hospital — Sapporo, Japan (enrolling)
• Tohoku University Hospital — Sendai, Japan (enrolling)
• Shiga University Hospital — Shiga, Japan (enrolling)
• Tokyo National Hospital — Tokyo, Japan (enrolling)
• Fujita Health University Hospital — Toyoake, Japan (enrolling)
• Tosei General Hospital — Aichi, Japan (enrolling)
• Dokkyo University Hospital (Pulmonary Medicine and Clinical Immunology) — Utsunomiya, Japan

Full record on ClinicalTrials.gov

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