NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Endobronchial Silicone Valve for Patients With Emphysema

RecruitingNA

Sponsor: China-Japan Friendship Hospital

Conditions: Emphysema

Interventions: ESV, Optimal Medical Management (OMM)

Countries: China

The purpose of this research is to evaluate the efficacy and safety of endobronchial silicone valve in patients with severe emphysema.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

Beijing, Beijing Municipality, China