An Evaluation of the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients Wit… (NCT06035120) | Clinical Trial Compass
RecruitingNot Applicable
An Evaluation of the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients With Severe Emphysema
United States200 participantsStarted 2024-02-22
Plain-language summary
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.
Who can participate
Age range40 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Subject has a recent HRCT meeting the scan parameter requirements and performed within 3 months of the ICF signature date with the following findings at -910 Hounsfield Units:
✓. At least one (1) lobe with segmental emphysema destruction score ≥ 50%.
✓. Subject has heterogenous emphysema, defined as difference in emphysema destruction score of ≥ 15 between the density scores of the target lobe and the ipsilateral non-target lobe(s) per QCT report with % voxel density of \< -910 HU. For non-target lobes that include the RML, calculate the combination of non-target lobes as a single density score using volume-weighted percent.
✓. LUL, LLL, RUL, RLL, or RUL+RML are targets for valve intervention.
Exclusion criteria
✕. 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.
What they're measuring
1
Converters, responder rate
Timeframe: 45 days post-AeriSeal treatment (index or repeat)
. 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.
✕. Subject had 3 or more COPD exacerbations requiring hospitalization within 12 months preceding the ICF signature date or a COPD exacerbation requiring hospitalization within 8 weeks of the ICF signature date. Subjects may be re-considered for future enrollment.
✕. Subject has asthma as their primary diagnosis.
✕. Subject has chronic bronchitis (defined as greater than 4 tablespoons of sputum production per day) as their primary diagnosis.
✕. Subject has clinically significant bronchiectasis.