Evaluating the AeriSeal System to Change Collateral Ventilation Status in Patients Aged 40-80 with Severe Emphysema

What this Trial Is About

This research aims to evaluate the AeriSeal System in patients with severe, heterogeneous emphysema who have collateral ventilation CV in the lung lobe targeted for treatment. The study is prospective, open-label, and conducted at multiple centers, including up to 200 subjects. Participants must be candidates for bronchoscopic lung volume reduction BLVR and will be followed for 24 months to assess safety and effectiveness. Participants meeting eligibility will undergo a bronchoscopy under general anesthesia to confirm CV status using the Chartis system. All enrolled subjects will receive the AeriSeal procedure to block collateral ventilation by closing lung fissure gaps. If CV status remains positive after the first treatment, a repeat AeriSeal treatment may be performed, with volume limits. Subjects who convert from CV positive to CV negative will then receive BLVR with a Zephyr Valve. Follow-up continues through 24 months for all participants. During the study, researchers will assess the conversion of collateral ventilation status 45 days after AeriSeal treatment as the primary outcome. Additional measures include lung function tests such as forced expiratory volume FEV1, residual volume RV, treated lobe volume reduction by CT scan, and quality of life questionnaires at 6 months after Zephyr Valve placement. Safety assessments and monitoring will continue throughout the study period, lasting up to two years per participant.

An Evaluation of the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients With Severe Emphysema