Endobronchial Silicone Valve for Patients With Emphysema
ConditionEmphysema
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChina-Japan Friendship Hospital
About this trial
The purpose of this research is to evaluate the efficacy and safety of endobronchial silicone valve in patients with severe emphysema.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- ESV
- Optimal Medical Management (OMM)
Treatment groups
147 Participants
are divided into 2 treatment groupsSponsors and collaborators
China-Japan Friendship Hospital
Lead sponsor
Beijing Cardiotech Medical Technology CO., LTD
Collaborator
Source ClinicalTrials.gov