Clinical trial NCT06655428: The REDUCE EU Study - Endobronchial Thermal Liquid Ablation (ETLA) for the Treatment of Emphysema
Official title: The REDUCE EU Study - Endobronchial Thermal Liquid Ablation (ETLA) for the Treatment of Emphysema - A Pilot Study (CSP-12123)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Morair Medtech, LLC
Sponsor class: INDUSTRY
First posted: 2024-10-23
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study is prospective, single-arm and multi-center.
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Percent of procedures where the device operated as intended
timeFrame: Through completion of the second procedure, approximately 13 weeks
measure: Incidence of serious adverse events (SAE)
timeFrame: 6 months
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: 9 months
measure: Incidence of serious adverse events (SAE)
timeFrame: 9 months
measure: Residual volume (RV) change
timeFrame: 3, 6, and 9 months
measure: FEV1 change
timeFrame: 3, 6, and 9 months
measure: RV/TLC change
timeFrame: 3, 6, and 9 months
measure: 6MWT change
timeFrame: 3, 6, and 9 months
measure: SGRQ-C change
timeFrame: 3, 6, and 9 months
Other outcomes:
measure: Target Lobe Volume Reduction
timeFrame: Baseline to 3 months post-procedure 1, 3 months post-procedure 1 to 3 months post-procedure 2
measure: Cumulative Lobar Volume Reduction
timeFrame: Through follow-up of the second procedure, approximately 6 Months
measure: Catheter positioning allowing treatment
timeFrame: Through completion of the second procedure, approximately 13 weeks
measure: Heated saline at predetermined volume
timeFrame: Through completion of the second procedure, approximately 13 weeks
measure: Auxiliary reduction
timeFrame: Through follow-up of the second procedure, approximately 6 Months
measure: Responder analyses
timeFrame: 3, 6, and 9 months
measure: TLC change
timeFrame: 3, 6, and 9 months
measure: CAT score change
timeFrame: 3, 6, and 9 months
measure: BODE index change
timeFrame: 3, 6, and 9 months
measure: DLCO change
timeFrame: 3, 6, and 9 months
measure: mMRC change
timeFrame: 3, 6, and 9 months
Locations:
city: Vienna
country: Austria
facility: Universitätsklinikum Allgemeines Krankenhaus Wien
city: Vienna
country: Austria
facility: Klinik Floridsdorf
city: Berlin
country: Germany
facility: Gemeinschaftskrankenhaus Havelhöhe gGmbH Klinik für Anthroposophische Medizin
city: Gauting
country: Germany
facility: Asklepios Lungenklinik Gauting GmbH
city: Hamburg
country: Germany
facility: Asklepios Klinik Barmbek
city: Heidelberg
country: Germany
facility: Thoraxklinik University of Heidelberg
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
state: The Netherlands
Study officials:
References: