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

NCT06655428 | Recruiting

• 2 other identifiers: CSP-12123CIV-24-04-046660
• Study Type: interventional
• Target: 30
• Locations: 3 countries
• Sites: 7

Brief Summary

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.

Conditions

Emphysema or COPD; Emphysema; Emphysema, Pulmonary; COPD; COPD (Chronic Obstructive Pulmonary Disease)

Keywords

Lung Volume Reduction; bronchoscopic lung volume reduction; ETLA; BTVA; LVR; Lung Disease, obstructive; Chronic Obstructive Lung Disease; Respiratory Tract Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Incidence of adverse events

  9 months

• Incidence of serious adverse events (SAE)

  9 months

• Residual volume (RV) change

  3, 6, and 9 months

• FEV1 change

  3, 6, and 9 months

• RV/TLC change

  3, 6, and 9 months

Other Outcomes (11)

• Target Lobe Volume Reduction

  Baseline to 3 months post-procedure 1, 3 months post-procedure 1 to 3 months post-procedure 2

• Cumulative Lobar Volume Reduction

  Through follow-up of the second procedure, approximately 6 Months

• Catheter positioning allowing treatment

  Through completion of the second procedure, approximately 13 weeks

Study Arms (1)

Endobronchial Thermal Liquid Ablation (ETLA) Treatment

EXPERIMENTAL

Participants will undergo up to two ETLA procedures separated by a minimum three-month interval.

Device: Endobronchial Therman Liquid Ablation (ETLA)

Interventions

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.

Also known as: Bronchoscopic lung volume reduction

Endobronchial Thermal Liquid Ablation (ETLA) Treatment

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• ml 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

Sponsors & Collaborators

• Morair Medtech, LLC: lead

Study Sites (7)

Universitätsklinikum Allgemeines Krankenhaus Wien

Vienna, Austria, 1090, Austria

NOT YET RECRUITING

Klinik Floridsdorf

Vienna, Austria, 1210, Austria

RECRUITING

Gemeinschaftskrankenhaus Havelhöhe gGmbH Klinik für Anthroposophische Medizin

Berlin, Germany, 14089, Germany

RECRUITING

Asklepios Lungenklinik Gauting GmbH

Gauting, Germany, 82131, Germany

NOT YET RECRUITING

Asklepios Klinik Barmbek

Hamburg, Germany, 22307, Germany

NOT YET RECRUITING

Thoraxklinik University of Heidelberg

Heidelberg, Germany, 22307, Germany

NOT YET RECRUITING

University Medical Center Groningen

Groningen, The Netherlands, 9700, Netherlands

NOT YET RECRUITING

MeSH Terms

Conditions

Emphysema; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Lung Diseases, Obstructive; Respiratory Tract Diseases

Interventions

Pneumonectomy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases; Chronic Disease; Disease Attributes

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study is prospective, single-arm and multi-center.

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 23, 2024
• Study Start: January 10, 2025
• Primary Completion: February 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

AU (2); DE (4); NL (1)