The goal of this clinical trial is to learn if bronchoscopic lung volume reduction with endobronchial thermal liquid ablation (ETLA) works to treat severe emphysema in terms of feasibility and safety.
Participants will:
* Have up to two ETLA procedures * Complete five clinic follow-up visits and two virtual follow-up visits.
Age ≥ 40 years old
Diagnosis of COPD with FEV1/FVC less than 0.7 post-bronchodilation
Post-bronchodilator Forced Expiratory Volume (FEV1) ≥ 20% and ≤ 49% of predicted value
Total lung capacity (TLC) ≥ 100% predicted
Body mass index (BMI) < 16 kg/m² or ≥ 33 kg/m²
DLCO < 20% predicted
Chronic bronchitis as defined by cough and sputum production for at least 3 months per year for two consecutive years, in the absence of other conditions that can explain these symptoms
75ml or greater sputum production per day most days of the week
Single group
Endobronchial Therman Liquid Ablation (ETLA)
DeviceThe ETLA System is a minimally invasive bronchoscopic treatment designed to deliver heated normal saline to targeted emphysematous lung regions with hyperinflation to cause tissue ablation and subsequent volume reduction as a means for treating emphysema. The ETLA procedures will be performed under general anesthesia. Each procedure will be limited to treatment in a single lung, with either unilateral or bilateral treatment over the two procedures.
Percent of procedures where the device operated as intended
Percent of procedures where the device operated as intended per the Instructions for Use (IFU)
Incidence of serious adverse events (SAE)
Incidence of serious adverse events (SAE) associated with the ETLA device and/or procedure as adjudicated by an independent medical monitor.
Incidence of adverse events
Incidence of all adverse events associated with the ETLA device and/or procedure
Incidence of serious adverse events (SAE)
Incidence of serious adverse events (SAE) associated with the ETLA device and/or procedure as adjudicated by an independent medical monitor
Residual volume (RV) change
Change in residual volume (RV) (mL, % change in absolute and % predicted)
FEV1 change
Change in Forced Expiratory Volume in the first second (FEV1) (mL, % change in absolute and % predicted)
Target Lobe Volume Reduction
Target Lobe Volume Reduction (TLVR) as measured by CT scan quantified by the reduction in the volume of the targeted lobe(s) (reported in mL)
Cumulative Lobar Volume Reduction
Cumulative Lobar Volume Reduction as measured by CT scan, quantified by the summation of TLVR through both procedures (reported in mL)
Catheter positioning allowing treatment
Percent of target regions where the catheter is placed in the target airway with positioning allowing treatment
Heated saline at predetermined volume
Percent of target regions where heated saline is delivered at the predetermined volume per treatment plan
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