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| ID | Type | Description | Link |
|---|---|---|---|
| CIV-24-04-046660 | Other Identifier | European Commission |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endobronchial Thermal Liquid Ablation (ETLA) Treatment | Experimental | Participants will undergo up to two ETLA procedures separated by a minimum three-month interval. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endobronchial Therman Liquid Ablation (ETLA) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of procedures where the device operated as intended | Percent of procedures where the device operated as intended per the Instructions for Use (IFU) | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Incidence of all adverse events associated with the ETLA device and/or procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline to 3 months post-procedure 1, 3 months post-procedure 1 to 3 months post-procedure 2 |
| Cumulative Lobar Volume Reduction |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Allgemeines Krankenhaus Wien | Not yet recruiting | Vienna | Austria | 1090 | Austria |
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The study is prospective, single-arm and multi-center.
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|
|
| 9 months |
| Residual volume (RV) change | Change in residual volume (RV) (mL, % change in absolute and % predicted) | 3, 6, and 9 months |
| FEV1 change | Change in Forced Expiratory Volume in the first second (FEV1) (mL, % change in absolute and % predicted) | 3, 6, and 9 months |
| RV/TLC change | Change in residual volume (RV) over total lung capacity (TLC) (RV/TLC) | 3, 6, and 9 months |
| 6MWT change | Change in Six Minute Walk Test (6MWT) | 3, 6, and 9 months |
| SGRQ-C change | Change in SGRQ-C (Saint George Respiratory Questionnaire-COPD) | 3, 6, and 9 months |
Cumulative Lobar Volume Reduction as measured by CT scan, quantified by the summation of TLVR through both procedures (reported in mL) |
| Through follow-up of the second procedure, approximately 6 Months |
| Catheter positioning allowing treatment | Percent of target regions where the catheter is placed in the target airway with positioning allowing treatment | Through completion of the second procedure, approximately 13 weeks |
| Heated saline at predetermined volume | Percent of target regions where heated saline is delivered at the predetermined volume per treatment plan | Through completion of the second procedure, approximately 13 weeks |
| Auxiliary reduction | Number of procedures where auxiliary reduction is observed in a region not predicted | Through follow-up of the second procedure, approximately 6 Months |
| Responder analyses | Responder analyses for:
| 3, 6, and 9 months |
| TLC change | Change in Total Lung Capacity (TLC) | 3, 6, and 9 months |
| CAT score change | Change in COPD Assessment Test (CAT) score | 3, 6, and 9 months |
| BODE index change | Change in BODE index (body-mass index, airflow obstruction, dyspnea, and exercise) | 3, 6, and 9 months |
| DLCO change | Change in DLCO (lung diffusion test) | 3, 6, and 9 months |
| mMRC change | Change in mMRC (Modified Medical Research Council dyspnea questionnaire) | 3, 6, and 9 months |
| Klinik Floridsdorf | Recruiting | Vienna | Austria | 1210 | Austria |
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| Gemeinschaftskrankenhaus Havelhöhe gGmbH Klinik für Anthroposophische Medizin | Recruiting | Berlin | Germany | 14089 | Germany |
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| Asklepios Lungenklinik Gauting GmbH | Not yet recruiting | Gauting | Germany | 82131 | Germany |
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| Asklepios Klinik Barmbek | Not yet recruiting | Hamburg | Germany | 22307 | Germany |
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| Thoraxklinik University of Heidelberg | Not yet recruiting | Heidelberg | Germany | 22307 | Germany |
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| University Medical Center Groningen | Not yet recruiting | Groningen | The Netherlands | 9700 | Netherlands |
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| ID | Term |
|---|---|
| D004646 | Emphysema |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D011656 | Pulmonary Emphysema |
| D008173 | Lung Diseases, Obstructive |
| D012140 | Respiratory Tract Diseases |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008171 | Lung Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| D011013 | Pneumonectomy |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D013510 | Pulmonary Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |
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