Commencement of the CONVERT II Pivotal Trial for AeriSeal® System: A Landmark Study by Pulmonx Corporation Aiming to Treat Severe COPD/Emphysema Patients
Overview
- Company: Pulmonx Corporation
- Indication: Chronic Obstructive Pulmonary Disease (COPD)/Emphysema
- Drug: AeriSeal® System followed by Zephyr® Valves
- Trial Phase: N/A
- NCT ID: NCT06035120
Trial Initiation Details
Pulmonx Corporation, a global leader in minimally invasive treatments for Chronic Obstructive Pulmonary Disease (COPD), has announced the start of patient treatment in the CONVERT II Pivotal Trial. This groundbreaking international multicenter trial aims to evaluate the effectiveness of the AeriSeal® System in reducing collateral ventilation, a common issue for patients with severe COPD/emphysema. The trial's launch was enabled by an FDA-staged IDE approval in late 2023.
Purpose of the Trial
The CONVERT II Pivotal Trial is designed to establish the safety and efficacy of the AeriSeal System in sealing fissural defects that result in collateral ventilation. By doing so, it targets improving treatment outcomes for severe COPD/emphysema patients who are not eligible for bronchoscopic lung volume reduction with Zephyr Valves due to this anatomical complication.
Methodology
Patients enrolled in the trial will first be evaluated using Pulmonx's proprietary Chartis® Pulmonary Assessment System to determine the presence of collateral ventilation. Those treated with the AeriSeal System will undergo a subsequent assessment 45 days later to verify successful occlusion of lung fissures. Patients demonstrating a positive response will then be treated with Zephyr Valves according to the standard lung volume reduction protocols.
Trial Scope and Expectations
The trial aims to recruit approximately 200 patients from 30 international sites, including locations in the United States, Australia, and Europe. Data on key outcomes such as lung function, quality of life, and exercise capacity will be collected after a 6-month period post-valve treatment. This critical data will support a Pre-Market Approval application.
Impact on Treatment Landscape
Pulmonx's initiation of the CONVERT II Pivotal Trial underscores their dedication to innovation and the potential for a shift in the treatment paradigm for severe COPD/emphysema patients with collateral ventilation.