Fissure Closure With the AeriSeal System for CONVERTing Collateral Ventilation Status (CONVERT) - Trial NCT04559464
Access comprehensive clinical trial information for NCT04559464 through Pure Global AI's free database. This phase not specified trial is sponsored by Pulmonx Corporation and is currently Recruiting. The study focuses on Emphysema,COPD,Severe Emphysema. Target enrollment is 140 participants.
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Study Focus
Sponsor & Location
Pulmonx Corporation
Timeline & Enrollment
N/A
Dec 15, 2020
Feb 01, 2023
Primary Outcome
Percentage of subjects converted from a positive collateral ventilation status (CV+) to having little to no collateral ventilation (CV-) in the treated lobe.,Treated Lobe Volume Reduction (TLVR) responders
Summary
This is a prospective, open-label, multi-center, single-arm study to be conducted at up to 15
 investigational sites. The Study plans to enroll 140 subjects with severe emphysema and
 collateral ventilation in the target lobe. This protocol is designed to evaluate the utility
 of the AeriSeal System to occlude collateral air channels in a target lung lobe with
 collateral ventilation (CV) and convert the target lung lobe to having little to no
 collateral ventilation. Subjects can then receive Zephyr Valves to achieve atelectasis in the
 targeted lobe, once AeriSeal has converted the CV+ lobe to a CV- one. Therefore, the study
 will have two Stages:
 
 • Stage 1 will address the closure of the lobar fissure gaps (or collateral air channels) to
 block collateral ventilation (CV) with the AeriSeal System; conversion of the CV+ target lobe
 to CV-. Conversion of collateral ventilation will be evaluated by Chartis after 45 days. In
 the case of unsuccessful conversion, a second treatment of AeriSeal may be attempted,
 provided that the total application volume from both the initial and the repeat treatments
 does not exceed 40 mL in up to three (3) segments.
 
 Clinical Assessments post-AeriSeal will be conducted at 28 and 45 days after first treatment
 and repeated after the second treatment, if applicable. For the purpose of protocol
 follow-up, the Day 45 post-AeriSeal final treatment will equal Day 0 for Stage 2.
 
 • Stage 2 will include successfully converted subjects; CV+ to CV- conversion in Stage 1.
 Converted CV- target lobes will follow standard of care and receive CE marked Zephyr
 Endobronchial valves per the Zephyr IFU to perform bronchoscopic lung volume reduction
 (BLVR).
 
 Clinical assessments will be conducted at 45 Days, 3 and 6-months post-Zephyr Valve
 procedure.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT04559464
Device Trial