Actively Recruiting
Zephyr Valve Japan Post-Marketing Surveillance
Led by Pulmonx Corporation · Updated on 2024-12-13
140
Participants Needed
17
Research Sites
211 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Zephyr Valve Japan Post-Marketing Surveillance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eligible for bronchoscopic lung volume reduction (BLVR) with Zephyr Valve as determined by physician and Japanese guidelines
- Completed respiratory rehabilitation within the last 6 months
- Not actively smoking for at least 4 months
- Total lung capacity (TLC) of 100% or greater
- Residual volume (RV) of 175% or greater
- Forced expiratory volume in 1 second (FEV1) between 15% and 45% post-bronchodilator
- Six-minute walking distance (6MWD) between 100 and 500 meters
- Modified Medical Research Council (mMRC) dyspnea score of 2 or higher
- No coagulation disorder
- No active respiratory infection
- Little to no collateral ventilation (CV-) confirmed by Chartis assessment
- Willing and able to provide informed consent
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 17 locations
1
Tosei General Hospital
Aichi, Japan
Actively Recruiting
2
Gifu Prefectural Medical Center
Gifu, Japan
Actively Recruiting
3
Kanagawa Cardio Chest Center
Kanagawa, Japan
Actively Recruiting
4
Kanazawa University Hospital
Kanazawa, Japan
Actively Recruiting
5
St Marianna University Hospital
Kawasaki, Japan
Actively Recruiting
6
Matsusaka Civic Hospital
Mie, Japan
Actively Recruiting
7
Nagasaki University Hospital
Nagasaki, Japan
Actively Recruiting
8
Nagoya Medical Center
Nagoya, Japan
Actively Recruiting
9
Okayama Medical Center
Okayama, Japan
Actively Recruiting
10
Kinki Chuo Chest Medical Center
Osaka, Japan
Actively Recruiting
11
Hokkaido University Hospital
Sapporo, Japan
Actively Recruiting
12
Tohoku University Hospital
Sendai, Japan
Actively Recruiting
13
Shiga University Hospital
Shiga, Japan
Actively Recruiting
14
Tokyo National Hospital
Tokyo, Japan
Actively Recruiting
15
Fujita Health University Hospital
Toyoake, Japan
Actively Recruiting
16
Dokkyo University Hospital (Pulmonary Medicine and Clinical Immunology)
Utsunomiya, Japan
Not Yet Recruiting
17
Dokkyo University Hospital
Utsunomiya, Japan
Actively Recruiting
Research Team
J
Joshua Percy
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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