Zephyr Valve Japan Post-Marketing Surveillance
Recruiting · NCT06332885 · Observational (researchers observe without assigning treatment) · Lead sponsor: Pulmonx Corporation
View the official record on ClinicalTrials.gov →Interventions studied
Zephyr Endobronchial Valve
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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
17 locations listed.
- Tosei General Hospital - Aichi, Japan
- Gifu Prefectural Medical Center - Gifu, Japan
- Kanagawa Cardio Chest Center - Kanagawa, Japan
- Kanazawa University Hospital - Kanazawa, Japan
- St Marianna University Hospital - Kawasaki, Japan
- Matsusaka Civic Hospital - Mie, Japan
- Nagasaki University Hospital - Nagasaki, Japan
- Nagoya Medical Center - Nagoya, Japan
- Okayama Medical Center - Okayama, Japan
- Kinki Chuo Chest Medical Center - Osaka, Japan
- Hokkaido University Hospital - Sapporo, Japan
- Tohoku University Hospital - Sendai, Japan
- Shiga University Hospital - Shiga, Japan
- Tokyo National Hospital - Tokyo, Japan
- Fujita Health University Hospital - Toyoake, Japan
- Dokkyo University Hospital (Pulmonary Medicine and Clinical Immunology) - Utsunomiya, Japan
- Dokkyo University Hospital - Utsunomiya, Japan