Recruiting

Surgery Plus Valves Versus Medical Care for Severe Emphysema

Plain-English translation of NCT04801108 on ClinicalTrials.gov ↗ · Source last updated April 2026 · Translation generated June 2026 · How we translate trials

What is this trial?

This trial is testing a combined approach using the Zephyr Valve System along with a surgical procedure to treat severe emphysema. In emphysema, the lungs lose their elasticity and air gets trapped, making it hard to breathe. This study compares two groups: one receives both surgery and the valve treatment, while the other receives standard medical management to see which approach helps people breathe better and improve quality of life.

Many people with severe emphysema struggle with breathing even with the best medicines available. Researchers want to see if combining surgery to complete the separation between lung sections (fissure completion) with valve placement can reduce lung volume and help people breathe easier than medical treatment alone.

Do you qualify?

You likely qualify if…

you are between 40 and 75 years old
you have been diagnosed with severe emphysema or COPD
you have not smoked for at least 4 months before starting and are willing to avoid smoking during the study
you have completed a pulmonary rehabilitation program within the past year
you are up to date on pneumococcus and influenza vaccinations
your lungs show incomplete fissure separation on a CT scan

You likely don't qualify if…

you have had a heart attack within the last 6 months
you have uncontrolled heart failure or severe high blood pressure in your lungs
you have had more than two episodes of pneumonia or more than two COPD flare-ups in the past year
you have had prior lung surgery, transplant, or certain other lung procedures
you cannot safely stop blood thinners or aspirin for 7 days before the procedure

What participation looks like

If you are randomly assigned to surgery, you will undergo a minimally invasive procedure where surgeons complete the separation of your lung sections and place valves in your airways—this typically happens under general anesthesia in an operating room. If you are assigned to medical management, you will receive the best available medicines for 3 months. Either way, you will complete breathing tests, walk tests, and quality-of-life questionnaires at the start and after 3 months to see how well the treatment is working. The entire study lasts about 3 months, with follow-up visits to measure improvements in your breathing and how you feel.

Surgery Plus Valves Versus Medical Care for Severe Emphysema

What is this trial?

Do you qualify?

What participation looks like

Trial locations(1 site)