Emphysema or COPDNCT06655428
The REDUCE EU Study - Endobronchial Thermal Liquid Ablation (ETLA) for the Treatment of Emphysema
A study testing Endobronchial Therman Liquid Ablation (ETLA) in people with Emphysema or COPD and Emphysema, run by Morair Medtech, LLC at 7 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Emphysema or COPD, Emphysema, Emphysema, Pulmonary
- What is being tested?
- Endobronchial Therman Liquid Ablation (ETLA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 10 Jan 2025to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
7 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 3 countries
Germany4 sites, 4 recruiting
- Recruiting
Gemeinschaftskrankenhaus Havelhöhe gGmbH Klinik für Anthroposophische Medizin
Berlin, Germany, 14089
Hannah Wüstefeld, Dr., +49 30 365 01-0, HannahFriederike.Wuestefeld@havelhoehe.de
Hannah Wüstefeld, Dr.
- Not yet recruiting
Asklepios Lungenklinik Gauting GmbH
Gauting, Germany, 82131
Christopher Breyer, Dr., +49 (0) 89 85791 ext. 5100, c.breyer@asklepios.com
Christopher Breyer, Dr.
- Not yet recruiting
Asklepios Klinik Barmbek
Hamburg, Germany, 22307
Ralf Eberhardt, Prof. Dr., +49(040) 181882 ext. 4800, reberhardt@asklepios.com
Ralf Eberhardt, Prof. Dr.
- Not yet recruiting
Thoraxklinik University of Heidelberg
Heidelberg, Germany, 22307
Felix Herth, Prof. Dr., +49 6221 396 1200, felix.herth@med.uni-heidelberg.de
Felix Herth, Prof. Dr.
Austria2 sites, 2 recruiting
- Not yet recruiting
Universitätsklinikum Allgemeines Krankenhaus Wien
Vienna, Austria, 1090
Daniela Gompelmann, Prof. Dr., +4314040047730, daniela.gompelmann@meduniwien.ac.at
Daniela Gompelmann, Prof. Dr.
- Recruiting
Klinik Floridsdorf
Vienna, Austria, 1210
Arschang Valipour, Prof. Dr., +43 1 277 00-72201, arschang.valipour@gesundheitsverbund.at
Arschang Valipour, Dr.
Netherlands1 site, 1 recruiting
- Not yet recruiting
University Medical Center Groningen
Groningen, The Netherlands, 9700
Dirk-Jan Slebos, Prof. Dr., +31 503612357, d.j.slebos@umcg.nl
Dirk-Jan Slebos, Prof. Dr.
About this study
Official title: 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.
Read the 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.
- Conditions
- Emphysema or COPD, Emphysema, Emphysema, Pulmonary, COPD, COPD (Chronic Obstructive Pulmonary Disease)
- Being tested
- Endobronchial Therman Liquid Ablation (ETLA)
- Keywords
- Lung Volume Reduction, bronchoscopic lung volume reduction, ETLA, BTVA, LVR, Lung Disease, obstructive, Chronic Obstructive Lung Disease, Respiratory Tract Disease
- Medical subject headings
- Emphysema, Pulmonary Disease, Chronic Obstructive, Pulmonary Emphysema, Lung Diseases, Obstructive, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endobronchial Therman Liquid Ablation (ETLA)Device
Also called Bronchoscopic lung volume reduction
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.
| Study group | Role | What they receive |
|---|---|---|
| Endobronchial Thermal Liquid Ablation (ETLA) Treatment | Experimental | Participants will undergo up to two ETLA procedures separated by a minimum three-month interval. Receives: Device: Endobronchial Therman Liquid Ablation (ETLA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of procedures where the device operated as intended
Percent of procedures where the device operated as intended per the Instructions for Use (IFU)
Measured: Through completion of the second procedure, approximately 13 weeks
Incidence of serious adverse events (SAE)
Incidence of serious adverse events (SAE) associated with the ETLA device and/or procedure as adjudicated by an independent medical monitor.
Measured: 6 months
Secondary outcomes (7)
Incidence of adverse events
Incidence of all adverse events associated with the ETLA device and/or procedure
Measured: 9 months
Incidence of serious adverse events (SAE)
Incidence of serious adverse events (SAE) associated with the ETLA device and/or procedure as adjudicated by an independent medical monitor
Measured: 9 months
Residual volume (RV) change
Change in residual volume (RV) (mL, % change in absolute and % predicted)
Measured: 3, 6, and 9 months
FEV1 change
Change in Forced Expiratory Volume in the first second (FEV1) (mL, % change in absolute and % predicted)
Measured: 3, 6, and 9 months
RV/TLC change
Change in residual volume (RV) over total lung capacity (TLC) (RV/TLC)
Measured: 3, 6, and 9 months
6MWT change
Change in Six Minute Walk Test (6MWT)
Measured: 3, 6, and 9 months
SGRQ-C change
Change in SGRQ-C (Saint George Respiratory Questionnaire-COPD)
Measured: 3, 6, and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start10 Jan 2025
- Primary completionFeb 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emphysema or COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study is prospective, single-arm and multi-center.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Morair Medtech, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655428
- Sponsor's protocol ID
- CSP-12123
- Other IDs
- CIV-24-04-046660
- Status last verified
- Jan 2025
- First submitted
- 17 Oct 2024
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The REDUCE EU Study - Endobronchial Thermal Liquid Ablation (ETLA) for the Treatment of Emphysema - A Pilot Study (CSP-12123)
- ClinicalTrials.gov ID
- NCT06655428
- Acronym / sponsor ID
- CSP-12123
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Morair Medtech, LLCIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study is prospective, single-arm and multi-center.
| Arm | Type | Receives |
|---|---|---|
| Endobronchial Thermal Liquid Ablation (ETLA) Treatment | Experimental | Device: Endobronchial Therman Liquid Ablation (ETLA)Participants will undergo up to two ETLA procedures separated by a minimum three-month interval. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (34 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endobronchial Therman Liquid Ablation (ETLA)Also: Bronchoscopic lung volume reductionThe 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. | Device | Endobronchial Thermal Liquid Ablation (ETLA) Treatment |
Primary outcome
Percent of procedures where the device operated as intended
Time frame: Through completion of the second procedure, approximately 13 weeks
Percent of procedures where the device operated as intended per the Instructions for Use (IFU)
Incidence of serious adverse events (SAE)
Time frame: 6 months
Incidence of serious adverse events (SAE) associated with the ETLA device and/or procedure as adjudicated by an independent medical monitor.
7 secondary outcomes
Incidence of adverse events
Time frame: 9 months
Incidence of serious adverse events (SAE)
Time frame: 9 months
Residual volume (RV) change
Time frame: 3, 6, and 9 months
FEV1 change
Time frame: 3, 6, and 9 months
RV/TLC change
Time frame: 3, 6, and 9 months
6MWT change
Time frame: 3, 6, and 9 months
SGRQ-C change
Time frame: 3, 6, and 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Universitätsklinikum Allgemeines Krankenhaus Wien
Vienna, Austria
Gemeinschaftskrankenhaus Havelhöhe gGmbH Klinik für Anthroposophische Medizin
Berlin, Germany
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endobronchial Therman Liquid Ablation (ETLA) in people with Emphysema or COPD and Emphysema, run by Morair Medtech, LLC at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, Austria, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of procedures where the device operated as intended (time frame: Through completion of the second procedure, approximately 13 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.