Actively Recruiting
The REDUCE EU Study - Endobronchial Thermal Liquid Ablation (ETLA) for the Treatment of Emphysema
Led by Morair Medtech, LLC · Updated on 2025-01-28
30
Participants Needed
7
Research Sites
68 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
The REDUCE EU Study - Endobronchial Thermal Liquid Ablation (ETLA) for the Treatment of Emphysema
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 40 years or older
- Diagnosis of COPD with FEV1/FVC less than 0.7 after bronchodilation
- Post-bronchodilator FEV1 between 20% and 49% of predicted value
- Total lung capacity 100% or more of predicted
- Residual lung volume 175% or more of predicted
- Able to walk at least 140 meters in 6 minutes
- Dyspnea score of 1 or higher on the modified Medical Research Council scale
- Blood gas levels with PCO2 55 mmHg or less and PO2 45 mmHg or more on room air
- Receiving optimized medical management as confirmed by the investigator
- Non-smoker for at least 3 months before enrollment confirmed by lab testing
- Regular physical exercise beyond daily living activities for more than 6 weeks before enrollment and agreement to continue
- Living within 1 hour of study hospital or regional care or willing to stay at hospital at least 5 days post-procedure
- Vaccinated for COVID-19, pneumococcus, and influenza or documented intolerance or refusal
- Able to give written informed consent and willing to follow study requirements
- Severe emphysematous lung areas eligible for ETLA treatment
You will not qualify if you...
- Body mass index less than 16 or 33 kg/m2 or more
- Lung diffusion capacity (DLCO) less than 20% predicted
- Chronic bronchitis with cough and sputum for at least 3 months per year for 2 years without other cause
- Producing 75 ml or more sputum per day most days
- More than two hospitalizations for COPD exacerbations or pneumonia in the past 12 months
- Asthma diagnosis confirmed by GINA guidelines
- Previous lung volume reduction with valves, coils, vapor, or polymer, unless valves removed more than 3 months ago under specific conditions
- Pulmonary hypertension
- Alpha-1 antitrypsin deficiency
- Uncontrolled diabetes mellitus
- Prior heart or lung transplant
- Heart attack or stroke within 12 months before enrollment
- Diagnosis of heart failure or hospitalization for heart failure within 6 months
- History of bleeding disorders or severe bleeding
- Unable to stop anti-coagulants or platelet inhibitors as required before and after procedures
- Daily systemic steroids over 15 mg prednisolone
- Use of immunosuppressive drugs for cancer, autoimmune disease, or transplant rejection prevention
- Pregnant, breastfeeding, or planning pregnancy during the study
- Currently in another experimental treatment trial
- Any condition likely to limit survival to less than one year
- Other illnesses or medications increasing risk with ETLA
- Conditions interfering with study evaluation or procedures including bronchoscopy
- Active aspergillus infection
- Clinically significant bronchiectasis or related radiological evidence
- Clinically significant pulmonary fibrosis
- Lung nodules not proven stable or benign
- Large lung bullae over one-third lung volume
- Prior lung volume reduction surgery, bullectomy, or lobectomy
- Remaining lung tissue too damaged for ETLA
- Active or recent respiratory infection within 4 weeks before screening or procedure
- COPD exacerbation within 6 weeks before screening or procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Universitätsklinikum Allgemeines Krankenhaus Wien
Vienna, Austria, Austria, 1090
Not Yet Recruiting
2
Klinik Floridsdorf
Vienna, Austria, Austria, 1210
Actively Recruiting
3
Gemeinschaftskrankenhaus Havelhöhe gGmbH Klinik für Anthroposophische Medizin
Berlin, Germany, Germany, 14089
Actively Recruiting
4
Asklepios Lungenklinik Gauting GmbH
Gauting, Germany, Germany, 82131
Not Yet Recruiting
5
Asklepios Klinik Barmbek
Hamburg, Germany, Germany, 22307
Not Yet Recruiting
6
Thoraxklinik University of Heidelberg
Heidelberg, Germany, Germany, 22307
Not Yet Recruiting
7
University Medical Center Groningen
Groningen, The Netherlands, Netherlands, 9700
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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