Endobronchial Silicone Valve for Patients With Emphysema
Recruiting · NCT07097896 · Interventional (participants receive a specific treatment) · Lead sponsor: China-Japan Friendship Hospital
View the official record on ClinicalTrials.gov →Interventions studied
ESVOptimal Medical Management (OMM)
What this trial is about
The purpose of this research is to evaluate the efficacy and safety of endobronchial silicone valve in patients with severe emphysema.
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 applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Clinical and radiological evidence of emphysema
- Nonsmoking for 4 months prior to screening interview
- BMI less than 35 kg/m2
- Stable on current medication regimen
- Forced expiratory volume in one second (FEV1) between 15% and 45% of predicted value
- Residual Volume less than 175% predicted (determined by body plethysmography)
- Little or no collateral ventilation (CV-) as determined using the Chartis System
Exclusion criteria
- Had two or more hospitalizations over the last year for a COPD exacerbation
- Had two or more hospitalizations over the last year for pneumonia
- Had a prior lung transplant, lung volume reduction surgery, bullectomy or lobectomy
- Had a heart attack or congestive heart failure within the last 6 months
- Have heart arrhythmia
- Is alpha-1 antitrypsin deficient
Where it is running
1 location listed.
- China-Japan Friendship Hospital - Beijing, Beijing Municipality, China