The REDUCE EU Study - Endobronchial Thermal Liquid Ablation (ETLA) for the Treatment of Emphysema

The REDUCE EU Study - Endobronchial Thermal Liquid Ablation (ETLA) for the Treatment of Emphysema - a Pilot Study (CSP-12123)

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.

Study Overview

• Status: Recruiting
• Conditions: Emphysema; COPD; Emphysema or COPD; COPD (Chronic Obstructive Pulmonary Disease); Emphysema, Pulmonary
• Intervention / Treatment: Device: Endobronchial Therman Liquid Ablation (ETLA)

Detailed Description

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
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1210
    • Recruiting
    • Klinik Floridsdorf
    • Contact: Arschang Valipour, Dr.
    • Contact: Arschang Valipour, Prof. Dr.; Phone Number: +43 1 277 00-72201; Email: arschang.valipour@gesundheitsverbund.at
  • Vienna, Austria, 1090
    • Not yet recruiting
    • Universitätsklinikum Allgemeines Krankenhaus Wien
    • Contact: Daniela Gompelmann, Prof. Dr.; Phone Number: +4314040047730; Email: daniela.gompelmann@meduniwien.ac.at
    • Contact: Daniela Gompelmann, Prof. Dr.
• Germany
  • Berlin, Germany, 14089
    • Recruiting
    • Gemeinschaftskrankenhaus Havelhöhe gGmbH Klinik für Anthroposophische Medizin
    • Contact: Hannah Wüstefeld, Dr.; Phone Number: +49 30 365 01-0; Email: HannahFriederike.Wuestefeld@havelhoehe.de
    • Contact: Hannah Wüstefeld, Dr.
  • Gauting, Germany, 82131
    • Not yet recruiting
    • Asklepios Lungenklinik Gauting GmbH
    • Contact: Christopher Breyer, Dr.; Phone Number: 5100 +49 (0) 89 85791; Email: c.breyer@asklepios.com
    • Contact: Christopher Breyer, Dr.
  • Hamburg, Germany, 22307
    • Not yet recruiting
    • Asklepios Klinik Barmbek
    • Contact: Ralf Eberhardt, Prof. Dr.; Phone Number: 4800 +49(040) 181882; Email: reberhardt@asklepios.com
    • Contact: Ralf Eberhardt, Prof. Dr.
  • Heidelberg, Germany, 22307
    • Not yet recruiting
    • Thoraxklinik University of Heidelberg
    • Contact: Felix Herth, Prof. Dr.
    • Contact: Felix Herth, Prof. Dr.; Phone Number: +49 6221 396 1200; Email: felix.herth@med.uni-heidelberg.de
• Netherlands
  • The Netherlands
    • Groningen, The Netherlands, Netherlands, 9700
      • Not yet recruiting
      • University Medical Center Groningen
      • Contact: Dirk-Jan Slebos, Prof. Dr.; Phone Number: +31 503612357; Email: d.j.slebos@umcg.nl
      • Contact: Dirk-Jan Slebos, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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
• Residual volume (RV) ≥ 175% predicted
• 6 Minute Walk Distance (6MWD) ≥ 140 meters
• Dyspnea scoring ≥ 1 on the modified Medical Research Council scale (mMRC)
• Blood gas values of PCO2 ≤ 55 mmHg; PO2 ≥ 45 mmHg on room air
• Optimized medical management (consistent with GOLD guidelines) as confirmed by the Investigator
• Non-smoking for 3 months prior to study enrollment, as confirmed by lab testing
• Participant must engages in physical exercise beyond activities of daily living (i.e., a walking program, pulmonary rehabilitation) on n a regular basis for more than 6 weeks prior to enrollment and agree to continue the activity throughout study participation
• Participant must live within approximately 1 hour of the study hospital, or live within 1 hour of adequate regional care, or be willing to remain in the hospital for at least five days post-procedure
• Vaccinated for COVID-19, pneumococcus, and influenza (per European Union and Member State guidelines) or documented clinical intolerance or documented patient refusal
• Cognitively able to provide written informed consent and willing to comply with study requirements
• Severe emphysematous lung subsegments eligible for ETLA treatment

Exclusion Criteria:

• Body mass index (BMI) < 16 kg/m^2 or ≥ 33 kg/m^2
• 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
• Greater than two hospitalizations for COPD exacerbations and/or pneumonia in the 12 months prior to enrollment
• Diagnosis of asthma that is confirmed according to the Global Initiative for Asthma (GINA) guidelines
• Prior lung volume reduction via endobronchial valves(s), coil(s), vapor and/or polymer. Patients whose valves have been removed > 3 months previously can be treated if a baseline bronchoscopy reveals no airway obstruction or obvious tissue granulation and the reason for valve removal was not for complications e.g., Pneumonia, severe exacerbation, or pneumothorax.
• Pulmonary hypertension
• Alpha-1 antitrypsin deficiency
• Uncontrolled diabetes mellitus
• Prior heart or lung transplant
• Myocardial infarction or stroke within the 12 months of enrollment
• Diagnosis of heart failure
• Heart failure requiring hospitalization, within 6 months prior to enrollment
• History of bleeding disorders or enhanced predisposition to bleeding
• History of severe/massive hemoptysis defined as >200ml of blood loss in < 24 hours
• Unable to discontinue anti-coagulants or platelet inhibitors (acetylsalicylic acid [ASA]and non-ASA, including low dose) for at least 7 days prior to each procedure (or as per physician discretion based on the specific agent) and for at least 6 weeks after each procedure
• Daily systemic steroids equivalent to > 15mg prednisolone
• Immunosuppressive drugs, such as for the treatment of cancer, autoimmune disease, or prevention of tissue/organ rejection
• Pregnant, lactating, or women of childbearing potential that plan to become pregnant within the study duration
• Currently enrolled in another trial studying an experimental treatment
• Any disease or condition likely to limit survival to less than one year
• Concomitant illnesses or medications that may pose a significant increased risk for complications following treatment with ETLA
• Any condition that would interfere with evaluation or completion of the study including study assessments and procedures, including bronchoscopy.
• Active aspergillus infection
• Clinically significant bronchiectasis as determined by the Investigator
• Radiological evidence of bronchiectasis in target region(s) and/or cystic radiological bronchiectasis in any region of the lungs
• Clinically significant pulmonary fibrosis
• Lung nodule not proven stable unless proven to have benign pathology
• Large bulla (defined as > 1/3 volume of a lung)
• Prior Lung Volume Reduction Surgery (LVRS), bullectomy, or lobectomy
• The remaining lung tissue NOT targeted for ETLA treatment is too highly diseased
• Active respiratory infection or recent respiratory infection with resolution < 4 weeks prior to screening or procedure
• Recent COPD exacerbation within < 6 weeks prior to screening or procedure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Endobronchial Thermal Liquid Ablation (ETLA) Treatment; Participants will undergo up to two ETLA procedures separated by a minimum three-month interval.

Device: Endobronchial Therman Liquid Ablation (ETLA); 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.; Other Names: Bronchoscopic lung volume reduction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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	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: Improvement in FEV1 of ≥ 12%; Reduction in RV of ≥ 6%; Reduction in RV/TLC of ≥ 3%; Increase in 6MWD of ≥ 26 meters; Improvement in SGRQ-C of ≥ 4 points	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

Collaborators and Investigators

• Sponsor: Morair Medtech, LLC

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2025
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: October 17, 2024
• First Submitted That Met QC Criteria: October 22, 2024
• First Posted (Actual): October 23, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 27, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: BTVA; Respiratory Tract Disease; Chronic Obstructive Lung Disease; LVR; Lung Volume Reduction; bronchoscopic lung volume reduction; ETLA; Lung Disease, obstructive
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
• Other Study ID Numbers: CSP-12123; CIV-24-04-046660 (Other Identifier: European Commission)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No