Tests a lung procedure using heat for severe emphysema

Trial details

Who runs it

Morair Medtech, LLC

Trial code

NCT06655428

Record updated

28 January 2025

Original description

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.Read full original descriptionShow less

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.

Inclusion: 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: Greater than two hospitalizations for COPD exacerbations and/or pneumonia in the 12 months prior to enrollment; 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; Prior heart or lung transplant; Heart failure requiring hospitalization, within 6 months prior to enrollment; Daily systemic steroids equivalent to > 15mg prednisolone; Concomitant illnesses or medications that may pose a significant increased risk for complications following treatment with ETLA; Prior Lung Volume Reduction Surgery (LVRS), bullectomy, or lobectomy; 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; 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; Pulmonary hypertension; Uncontrolled diabetes mellitus; Myocardial infarction or stroke within the 12 months of enrollment; Diagnosis of heart failure; History of bleeding disorders or enhanced predisposition to bleeding; History of severe/massive hemoptysis defined as >200ml of blood loss in < 24 hours; Immunosuppressive drugs, such as for the treatment of cancer, autoimmune disease, or prevention of tissue/organ rejection; Any disease or condition likely to limit survival to less than one year; Any condition that would interfere with evaluation or completion of the study including study assessments and procedures, including bronchoscopy; Active aspergillus infection; 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; Body mass index (BMI) < 16 kg/m\^2 or ≥ 33 kg/m\^2; DLCO < 20% predicted; 75ml or greater sputum production per day most days of the week; Diagnosis of asthma that is confirmed according to the Global Initiative for Asthma (GINA) guidelines; Alpha-1 antitrypsin deficiency; 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; 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); The remaining lung tissue NOT targeted for ETLA treatment is too highly diseased.

ClinicalTrials.gov NCT06655428