AeriSeal System for Emphysema

(CONVERT_II Trial)

This trial aims to evaluate the AeriSeal System for individuals with severe emphysema and collateral ventilation, which affects air movement in the lungs. The study tests whether sealing specific lung areas can improve breathing when combined with a valve to reduce lung volume. Participants should have severe emphysema with specific lung damage and breathing difficulties. This trial offers an opportunity for those who have stopped smoking and completed pulmonary rehab to explore new treatment options. As an unphased trial, it provides a unique chance for patients to contribute to innovative research and potentially benefit from cutting-edge treatment strategies.

The trial protocol does not specify if you need to stop taking your current medications. However, you must be on optimal medical management for at least one month before joining the study, and you may need to temporarily stop taking certain blood thinners like heparins and oral anticoagulants before procedures.

Research has shown that the AeriSeal System is generally safe for people with severe emphysema. In earlier studies, many patients underwent the AeriSeal procedure to block unwanted air paths in the lungs, and the results were encouraging. Most patients improved, with 77.6% experiencing a positive change in their lung condition, making them eligible for further treatment like the Zephyr Valve.

The AeriSeal system is unique because it aims to treat severe emphysema by blocking collateral ventilation, which is different from the way most current treatments work. Traditional treatments, like bronchodilators and steroids, focus on opening airways and reducing inflammation, but AeriSeal targets the structural problem of air leakage between lung lobes. This innovative approach involves closing lobar fissure gaps, which could improve lung function without the need for more invasive procedures. Researchers are excited because this method could offer a new avenue for patients who haven’t found relief with existing therapies.

Research has shown that the AeriSeal System, which participants in this trial will receive, effectively treats severe emphysema with extra airflow paths in the lungs. Studies found that 77.6% of patients transitioned from having these extra airflow paths to not having them after treatment with AeriSeal Foam. This indicates that the treatment successfully blocked unnecessary airflow in most patients, making them eligible for other procedures like the Zephyr Valve. Clinical data has proven the AeriSeal System safe and effective, with long-term benefits reported. These findings suggest that the AeriSeal System could improve lung function and quality of life for patients with severe emphysema.¹²⁵⁶⁷