RecruitingNot ApplicableNCT06655428

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)

Sponsor

Morair Medtech, LLC

Enrollment

30 participants

Start Date

Jan 10, 2025

Study Type

INTERVENTIONAL

Conditions

COPD Emphysema COPD, Chronic Obstructive Pulmonary Disease Emphysema or COPD Emphysema, Pulmonary

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.

Eligibility

Min Age: 40 Years

Inclusion Criteria15

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

Exclusion Criteria34

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
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

Interventions

DEVICEEndobronchial 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.