None listed
Conditions
Brief summary
This is a prospective, multi-center, single-arm phased study assessing the efficacy and safety of the ETLA system for the treatment of severe emphysema with hyperinflation. 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 therapy will be delivered sequentially over two (2) procedures. The magnitude of clinical benefit associated with ETLA is anticipated to correlate with the relative volume of diseased tissue removed/reduced, therefore it is anticipated that a higher relative saline dose may result in greater improvement.
Interventions
The Morair Medtech (Endobronchial Thermal Liquid Ablation) ETLA System is a medical device consisting of the ETLA catheter and generator and TRST (Treatment Regional Selection Tool). The ETLA System provides 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 REDUCE Optimization Study involves the completion o
The Morair Medtech (Endobronchial Thermal Liquid Ablation) ETLA System is a medical device consisting of the ETLA catheter and generator and TRST (Treatment Regional Selection Tool). The ETLA System provides 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 REDUCE Optimization Study involves the completion of two separate procedures using the ETLA System scheduled approximately 3 months apart. The delivery of the second treatment will be dependent upon the health and wellbeing of the participant (assessed prior to the second procedure). Each patient will be monitored and assessed for safety events and treatment efficacy for 9 months after the first ETLA procedure. The follow-up assessments will include regular pulmonary function tests, laboratory blood draws, and quality of life assessments The procedures will be performed in a bronchoscopy suite by a suitably qualified interventional pulmonologist (respiratory physician). ETLA therapy involves the delivery of up to 50ml of heated normal saline (0.9% Normal Saline) at 95 degrees celcius to lung regions identified by the treating physician using the TRST. The TRST presents the treating physician with possible subsegments to be treated based on an analysis of an HRCT of the patient’s chest. These selections are used to produce a treatment plan, including the associated dose for each subsegment, based on the individual’s specific airway volumes and disease severity. Treatment over the two ETLA procedures may be unliateral or bilateral, however only one lung can be treated in each of the two ETLA procedures. The decision as to which lung regions to treat during each procedure will be based upon disease severity and volume of lung segments and is ultimately up to the interventional pulmonologist. Subjects will be anaesthetised and paralysed for the procedure. Exact drugs and dosages of anaesthetic agents utlised will be decided on a patient by patient basis after assessment by a suitably qualified anaesthetist. The target lesions to undergo ETLA will be decided upon by the interventional pulmonologist based upon data obtained from analysis of High Resolution CT Scan (HRCT) of the chest of potential subjects. Following the decision of the interventional pulmonologist a treatment plan will be provided by Morair Medtech. Each procedure will target 5-15% of a participant's total lung volume. These volumes are based on volumetric CT analysis. The dose of saline delivered to the lungs will also be adjusted relative to a target ratio of saline to amount of lung region to be treated. Enrollment of the study will be conducted in two phases with the second half of the study, the last 15 of 30 participants, being treated with a slightly higher dose range (higher saline volume to target lung tissue). It is anticipated that the higher dose ratio will result in more complete lung volume reduction at a sub-segmental level and larger improvement in lung function. The ETLA procedure is expected to take approximately 1 hour from the time of the participant being placed on the operating table to the time of being removed from the table. As mentioned above the procedure will be performed in an operating theatre or interventional bronchoscopy suite. The safety and efficacy of the ETLA procedures will be monitored by a series of scheduled CT Scans throughout the 9 month follow-up period.
Sponsors
Morair Medtech LLC
ISI
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age greater than or equal to 40 years old 2. Diagnosis of COPD with FEV1/FVC less than 0.7 post-bronchodilation 3. Post-bronchodilator FEV1 greater than or equal to 20% and less than or equal to 49% of predicted value 4. Total lung capacity TLC greater than or equal to 100% predicted 5. Residual volume (RV) greater than or equal to 175% predicted 6. 6MWD greater than or equal to 140 meters 7. Dyspnea scoring greater than or equal to 1 on the modified Medical Research Council scale (mMRC) 8. PaCO2 less than or equal to 55 mmHg; PaO2 greater than or equal to 45 mmHg on room air 9. Optimized medical management (consistent with GOLD guidelines) as confirmed by the Investigator 10. Non-smoking for 3 months prior to study enrollment, as confirmed by: • Negative cotinine urine analysis or serum cotinine level of less than or equal to 10 ng/ml, OR • Negative carboxyhemoglobin (COHb) test (less than or equal to 2.5%) 11. The patient engages in physical exercise beyond activities of daily living (i.e., a walking program, pulmonary rehabilitation) • On a regular basis for more than 6 weeks, AND • Is continuing the activity at enrollment, AND • Agrees to continue the activity throughout study participation 12. Patient must meet ONE of the following criteria for distance from treating hospital: • Live within approximately 1 hour of the study hospital, OR • If > 1 hour from study hospital, patient lives within approximately 1 hour of regional care that is sufficient to handle an emergency pulmonary event in COPD patients or must be willing to remain in the hospital for at least 5 days post-procedure or stay at local accommodation for at least 5 days post-procedure 13. Vaccinated per general health recommendations during the global pandemic as well as pneumococcus and influenza (per Australian Government and State guidelines) or documented clinical intolerance or documented patient refusal 14. Cognitively able to provide written informed consent and willing to comply with study requirements 15. Severe emphysematous subsegments eligible for ETLA treatment
Exclusion criteria
1. Body mass index (BMI) < 16 kg/m2 or less than or equal to 33 kg/m2 2. DLCO < 20% predicted 3. 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 4. 75ml or greater sputum production per day most days of the week 5. Greater than two hospitalizations for COPD exacerbations and/or pneumonia in the 12 months prior to enrollment 6. Diagnosis of asthma that is confirmed according to the Global Initiative for Asthma (GINA) guidelines 7. 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. 8. Pulmonary hypertension: • History of cor pulmonale, OR • mPAP >20mm Hg in the 12 months prior to enrollment, OR • RV estimated systolic pressure >45 mmHg in the 12 months prior to enrollment 9. Alpha-1 antitrypsin deficiency 10. Uncontrolled diabetes mellitus with an HbA1c >9.0% within 6 months of enrollment 11. Prior heart or lung transplant 12. Myocardial infarction or stroke within the 12 months of enrollment 13. Diagnosis of heart failure: Left Ventricular Ejection Fraction (LVEF) less than or equal to 40% within 12 months prior to enrollment 14. Heart failure requiring hospitalization, within 6 months prior to enrollment 15. History of bleeding disorders or enhanced predisposition to bleeding 16. History of severe/massive hemoptysis defined as >200ml of blood loss in < 24 hours 17. Unable to discontinue anti-coagulants or platelet inhibitors (acetylsalicylic acid [ASA] >100mg and non-ASA) 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 18. Daily systemic steroids equivalent to > 15mg prednisone 19. Immunosuppressive drugs, such as for the treatment of cancer, autoimmune disease, or prevention of tissue/organ rejection 20. Pregnant, lactating, or women of childbearing potential that plan to become pregnant within the study duration 21. Currently enrolled in another trial studying an experimental treatment 22. Any disease or condition likely to limit survival to less than one year 23. Concomitant illnesses or medications that may pose a significant increased risk for complications following treatment with ETLA 24. Any condition that would interfere with evaluation or completion of the study including assessments and procedures, including bronchoscopy 25. Patients who qualify for endobronchial valves who have not been offered endobronchial valve therapy prior to inclusion in the REDUCE Optimization Study 26. Active aspergillus infection, including chronic aspergillus infection, aspergilloma, invasive aspergillosis, cavitation and/or history of aspergillus cavitation(s) or colonization confirmed by bronchoscopic culture* 27. Clinically significant bronchiectasis as determined by the Investigator 28. Radiological evidence of bronchiectasis in target region(s) and/or cystic radiological bronchiectasis in any region of the lungs* 29. Clinically significant pulmonary fibrosis* 30. Lung nodule not proven stable unless proven to have benign pathology* 31. Large bulla (defined as > 1/3 volume of a lung)* 32. Prior Lung Volume Reduction Surgery (LVRS), bullectomy, or lobectomy* 33. Contralateral lung tissue is too highly diseased, defined as %-950 = 50%, after both ETLA procedure treatment plans are finalized, as confirmed by QCT analysis 34. Active respiratory infection or recent respiratory infection with resolution < 4 weeks prior to screening or procedure 35. Recent COPD exacerbation within < 6 weeks prior to screening or procedure
Outcome results
None listed