Endobronchial silicone valve to help breathing in people with severe emphysema

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional trial compares endobronchial silicone valve placement plus optimal medical therapy to optimal medical therapy alone in adults with severe emphysema. The valve is implanted via bronchoscopy to reduce volume in diseased lung regions, which can allow healthier parts of the lung to work better. Participants are randomized in a 2:1 ratio to receive the valve or standard care and are followed to assess lung function and safety. The study aims to see if the valve improves breathing and quality of life beyond standard treatment. Outcomes focus on lung function, symptoms, and adverse events.

Why it matters

Who can join: the full rules

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's running

• China-Japan Friendship Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Mingming Deng, PhD., MD.
• Email: isdeng1017@163.com
• Phone: +86 18801336854

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.