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RecruitingNCT06655428Updated Jan 28, 2025

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

An interventional study of Endobronchial Therman Liquid Ablation (ETLA) in Emphysema or COPD, Emphysema and Emphysema, Pulmonary, sponsored by Morair Medtech, LLC. Recruiting at 7 sites in 3 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-01-28.

Sponsored by Morair Medtech, LLC · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Feb 2026, 8 months ago, but the record still lists the study as recruiting.
  • Started Jan 2025; still recruiting 1 year 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
40 Years and older
Sex
All
01

Study 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.
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.

02

Conditions studied

  • 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
03

In context

Emphysema

339 studies on the registry are indexed under Emphysema; 59 are open to participants now.

This study's planned enrollment of 30 is below the median of 48 across 208 interventional studies indexed under Emphysema.

Browse Emphysema studies →

Lead sponsor

This is the only study on the registry with Morair Medtech, LLC as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Endobronchial Thermal Liquid Ablation (ETLA) Treatment

    Participants will undergo up to two ETLA procedures separated by a minimum three-month interval.

    Device: Endobronchial Therman Liquid Ablation (ETLA)

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.

    Also known as: Bronchoscopic lung volume reduction

06

What researchers measure

Primary outcomes

  1. Percent of procedures where the device operated as intended

    Percent of procedures where the device operated as intended per the Instructions for Use (IFU)

    Time frame: Through completion of the second procedure, approximately 13 weeks

  2. 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.

    Time frame: 6 months

Secondary outcomes

  1. Incidence of adverse events

    Incidence of all adverse events associated with the ETLA device and/or procedure

    Time frame: 9 months

  2. 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

    Time frame: 9 months

  3. Residual volume (RV) change

    Change in residual volume (RV) (mL, % change in absolute and % predicted)

    Time frame: 3, 6, and 9 months

  4. FEV1 change

    Change in Forced Expiratory Volume in the first second (FEV1) (mL, % change in absolute and % predicted)

    Time frame: 3, 6, and 9 months

  5. RV/TLC change

    Change in residual volume (RV) over total lung capacity (TLC) (RV/TLC)

    Time frame: 3, 6, and 9 months

  6. 6MWT change

    Change in Six Minute Walk Test (6MWT)

    Time frame: 3, 6, and 9 months

  7. SGRQ-C change

    Change in SGRQ-C (Saint George Respiratory Questionnaire-COPD)

    Time frame: 3, 6, and 9 months

Other outcomes

  1. Target Lobe Volume Reduction

    Target Lobe Volume Reduction (TLVR) as measured by CT scan quantified by the reduction in the volume of the targeted lobe(s) (reported in mL)

    Time frame: Baseline to 3 months post-procedure 1, 3 months post-procedure 1 to 3 months post-procedure 2

  2. Cumulative Lobar Volume Reduction

    Cumulative Lobar Volume Reduction as measured by CT scan, quantified by the summation of TLVR through both procedures (reported in mL)

    Time frame: Through follow-up of the second procedure, approximately 6 Months

  3. Catheter positioning allowing treatment

    Percent of target regions where the catheter is placed in the target airway with positioning allowing treatment

    Time frame: Through completion of the second procedure, approximately 13 weeks

  4. Heated saline at predetermined volume

    Percent of target regions where heated saline is delivered at the predetermined volume per treatment plan

    Time frame: Through completion of the second procedure, approximately 13 weeks

  5. Auxiliary reduction

    Number of procedures where auxiliary reduction is observed in a region not predicted

    Time frame: Through follow-up of the second procedure, approximately 6 Months

  6. Responder analyses

    Responder analyses for: * Improvement in FEV1 of ≥ 12% * Reduction in RV of ≥ 6% * Reduction in RV/TLC of ≥ 3% * Increase in 6MWD of ≥ 26 meters * Improvement in SGRQ-C of ≥ 4 points

    Time frame: 3, 6, and 9 months

  7. TLC change

    Change in Total Lung Capacity (TLC)

    Time frame: 3, 6, and 9 months

  8. CAT score change

    Change in COPD Assessment Test (CAT) score

    Time frame: 3, 6, and 9 months

  9. BODE index change

    Change in BODE index (body-mass index, airflow obstruction, dyspnea, and exercise)

    Time frame: 3, 6, and 9 months

  10. DLCO change

    Change in DLCO (lung diffusion test)

    Time frame: 3, 6, and 9 months

  11. mMRC change

    Change in mMRC (Modified Medical Research Council dyspnea questionnaire)

    Time frame: 3, 6, and 9 months

07

Study locations

2 of 7 sites recruiting
  • Universitätsklinikum Allgemeines Krankenhaus Wien
    Vienna, Austria 1090, Austria
    Not yet recruiting
  • Klinik Floridsdorf
    Vienna, Austria 1210, Austria
    Recruiting
  • Gemeinschaftskrankenhaus Havelhöhe gGmbH Klinik für Anthroposophische Medizin
    Berlin, Germany 14089, Germany
    Recruiting
  • Asklepios Lungenklinik Gauting GmbH
    Gauting, Germany 82131, Germany
    • Christopher Breyer, Dr. · Contact · c.breyer@asklepios.com · +49 (0) 89 85791
    • Christopher Breyer, Dr. · Principal investigator
    Not yet recruiting
  • Asklepios Klinik Barmbek
    Hamburg, Germany 22307, Germany
    • Ralf Eberhardt, Prof. Dr. · Contact · reberhardt@asklepios.com · +49(040) 181882
    • Ralf Eberhardt, Prof. Dr. · Principal investigator
    Not yet recruiting
  • Thoraxklinik University of Heidelberg
    Heidelberg, Germany 22307, Germany
    Not yet recruiting
  • University Medical Center Groningen
    Groningen, The Netherlands 9700, Netherlands
    • Dirk-Jan Slebos, Prof. Dr. · Contact · d.j.slebos@umcg.nl · +31 503612357
    • Dirk-Jan Slebos, Prof. Dr. · Principal investigator
    Not yet recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2025 (actual). Primary completion is estimated for Feb 2026, 13 months after the start.

Of 61 interventional studies with no phase under Emphysema, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 51. This study's planned 13 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 17, 2024
First posted
Oct 23, 2024
StartActual
Jan 10, 2025
Primary completionEst.
Feb 2026
CompletionEst.
May 2026
Last update
Jan 28, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06655428
Lead sponsor
Morair Medtech, LLC
Responsible party
Sponsor
First posted
Oct 23, 2024
Start date
Jan 10, 2025
Primary completion
Feb 2026 (estimated)
Completion
May 2026 (estimated)
Last update
Jan 28, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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