Endobronchial thermal liquid ablation for treating emphysema

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

This study is testing a new treatment called endobronchial thermal liquid ablation to see if it can safely help people with severe emphysema breathe better and improve their quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: Morair Medtech, LLC (Industry-sponsored)
• Locations: 7 sites (Vienna, Austria and 6 other locations)
• Trial ID: NCT06655428 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the feasibility and safety of endobronchial thermal liquid ablation (ETLA) as a treatment for severe emphysema. Participants will undergo up to two ETLA procedures and will have multiple follow-up visits to assess their pulmonary function and quality of life. The study will also investigate the efficacy of sequential ETLA treatments in improving outcomes for patients with this condition.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 40 and older with a diagnosis of COPD and specific pulmonary function criteria.

Not a fit: Patients with mild emphysema or those who do not meet the specific pulmonary function criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve lung function and quality of life for patients suffering from severe emphysema.

How similar studies have performed: Other studies have shown promise with similar bronchoscopic lung volume reduction techniques, suggesting potential for success with this novel approach.

Eligibility criteria

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

Where this trial is running

Vienna, Austria and 6 other locations

• Universitätsklinikum Allgemeines Krankenhaus Wien — Vienna, Austria, Austria (Not_yet_recruiting)
• Klinik Floridsdorf — Vienna, Austria, Austria (Recruiting)
• Gemeinschaftskrankenhaus Havelhöhe gGmbH Klinik für Anthroposophische Medizin — Berlin, Germany, Germany (Recruiting)
• Asklepios Lungenklinik Gauting GmbH — Gauting, Germany, Germany (Not_yet_recruiting)
• Asklepios Klinik Barmbek — Hamburg, Germany, Germany (Not_yet_recruiting)
• Thoraxklinik University of Heidelberg — Heidelberg, Germany, Germany (Not_yet_recruiting)
• University Medical Center Groningen — Groningen, The Netherlands, Netherlands (Not_yet_recruiting)

Conditions Emphysema or COPD; Emphysema; Emphysema, Pulmonary; COPD; Lung Volume Reduction; bronchoscopic lung volume reduction; ETLA; BTVA