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.
ETLA offers the potential to result in significant lung volume reduction of hyperinflated emphysematous regions, providing clinically meaningful improvement in pulmonary function and quality of life to a broad population of patients with severe emphysema. The REDUCE EU Pilot study will primarily evaluate the feasibility and safety of ETLA treatment in patients with severe emphysema. Secondarily, the study will evaluate the efficacy of sequential ETLA treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The 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.
Universitätsklinikum Allgemeines Krankenhaus Wien
Vienna, Austria, Austria
NOT_YET_RECRUITINGKlinik Floridsdorf
Vienna, Austria, Austria
RECRUITINGGemeinschaftskrankenhaus Havelhöhe gGmbH Klinik für Anthroposophische Medizin
Berlin, Germany, Germany
RECRUITINGAsklepios Lungenklinik Gauting GmbH
Gauting, Germany, Germany
NOT_YET_RECRUITINGAsklepios Klinik Barmbek
Hamburg, Germany, Germany
NOT_YET_RECRUITINGThoraxklinik University of Heidelberg
Heidelberg, Germany, Germany
NOT_YET_RECRUITINGUniversity Medical Center Groningen
Groningen, The Netherlands, Netherlands
NOT_YET_RECRUITINGPercent of procedures where the device operated as intended
Percent of procedures where the device operated as intended per the Instructions for Use (IFU)
Time frame: Through completion of the second procedure, approximately 13 weeks
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.
Time frame: 6 months
Incidence of adverse events
Incidence of all adverse events associated with the ETLA device and/or procedure
Time frame: 9 months
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
Time frame: 9 months
Residual volume (RV) change
Change in residual volume (RV) (mL, % change in absolute and % predicted)
Time frame: 3, 6, and 9 months
FEV1 change
Change in Forced Expiratory Volume in the first second (FEV1) (mL, % change in absolute and % predicted)
Time frame: 3, 6, and 9 months
RV/TLC change
Change in residual volume (RV) over total lung capacity (TLC) (RV/TLC)
Time frame: 3, 6, and 9 months
6MWT change
Change in Six Minute Walk Test (6MWT)
Time frame: 3, 6, and 9 months
SGRQ-C change
Change in SGRQ-C (Saint George Respiratory Questionnaire-COPD)
Time frame: 3, 6, and 9 months
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