An Evaluation of the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients With Severe Emphysema
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorPulmonx Corporation
About this trial
This is a prospective, open-label, multi-center, single-arm study planned to enroll 200 subjects with heterogeneous emphysema and collateral ventilation (CV) in the target lobe. Subjects will undergo instillation of AeriSeal Foam in the target lobe and subsequent assessment of CV status using Chartis Pulmonary Assessment System. Subjects with CV- status will then undergo placement of Zephyr Valve in the target lobe for bronchoscopic lung volume reduction (BLVR) and be followed for 24 months.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject is willing and able to provide informed consent and to participate in the study.
Subject is aged ≥ 40 and ≤ 80 years at the time of the ICF signature date.
Subject has completed a documented pulmonary rehabilitation (in clinic or home-based) program within 12 months prior to Baseline.
Subject has stopped smoking for at least 8 weeks prior to the ICF signature date as confirmed by carboxyhemoglobin or cotinine levels.
Disqualifiers
Subject has prior lung volume reduction surgery, lobectomy or pneumonectomy, lung transplantation, airway stent placement, pleurodesis, or BLVR of any type, except BLVR using Zephyr Valve with < 50% TLVR at 6 months, followed by valve removal > 6 months prior to ICF signature date.
Subject has visible radiological abnormality on HRCT scan such as pulmonary nodule greater than 0.8 cm in diameter (does not apply, if present for 2 years or more without increase in size or if deemed benign by biopsy) or active pulmonary infection (e.g., unexplained parenchymal infiltrate, significant interstitial lung disease or significant pleural disease).
Post-COVID-19 pathology on CT, including ground glass opacities with or without consolidation, adjacent pleura thickening, interlobular septal thickening, or air bronchograms.
Large bullae encompassing greater than 1/3 of the total lung.
Trial design
Design model
Single group
Treatments tested in this trial
AeriSeal System
DeviceThe AeriSeal System comprises AeriSeal Foam and the AeriSeal Balloon Catheter Preparation Kit that is used for bronchoscopic delivery of AeriSeal Foam to the targeted regions of the lung.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: AeriSealExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Converters, responder rate
The percentage of study subjects that successfully convert from a positive collateral ventilation status (CV+) in the treated lobe to having little to no collateral ventilation (CV-) by Chartis.
Time frame
45 days post-AeriSeal treatment (index or repeat)Secondary outcomes
1
Post-bronchodilator forced expiratory volume in 1 second (FEV1), responder rate
The percentage of converters achieving a ≥ 12% increase in FEV1
Time frame
Month 6 post-Zephyr Valve2
Residual volume (RV), responder rate
The percentage of converters achieving a ≥ 310 mL decrease in RV
Time frame
Month 6 post-Zephyr Valve3
Treated lobe volume reduction (TLVR) by high-resolution computed tomography (HRCT), responder rate
The percentage of converters achieving a ≥ 350 mL decrease in TLVR
Time frame
Month 6 post-Zephyr Valve4
St. George's Respiratory Questionnaire (SGRQ), responder rate
The percentage of converters achieving a ≥ 4-point decrease in SGRQ total score
Time frame
Month 6 post-Zephyr ValveOther outcomes
1
Post-bronchodilator forced expiratory volume in 1 second (FEV1) change
Absolute, percent and percent predicted change
Time frame
Month 3, Month 6, Month 12, Month 242
Post-bronchodilator forced expiratory volume in 1 second (FEV1), responder rate
Percentage of subjects achieving a ≥12% increase
Time frame
Month 3, Month 12, Month 243
Residual volume (RV), responder rate
The percentage of subjects achieving a ≥ 310 mL decrease in RV
Time frame
Month 3, Month 12, Month 244
Residual volume (RV), change
Absolute and percent predicted change in RV
Time frame
Day 45, Month 6, Month 12Sponsors and contacts
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Source ClinicalTrials.gov