COPD emphysema COPD emphysema
Conditions
Interventions
Subjects will undergo two (2) ETLA procedures separated by a minimum three (3) month interval. Each procedure will be limited to treatment in a single lung, with either unilateral or bilateral treatme
Sponsors
Intuitive Surgical Operations, Inc
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age = 40 years old 2. Diagnosis of COPD with FEV1/FVC less than 0.7 post-bronchodilation 3. Post-bronchodilator FEV1 = 20% and = 49% of predicted value 4. Total lung capacity TLC = 100% predicted 5. Residual volume (RV) = 175% predicted 6. 6MWD = 140 meters 7. Dyspnea scoring = 1 on the modified Medical Research Council scale (mMRC) 8. PCO2 = 55 mmHg; PO2 > 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 = 10 ng/ml OR • Negative carboxyhemoglobin (COHb) test (= 2.5%) Note: Carboxyhemoglobin is required for patients who are using smoking cessation products containing nicotine at screening 11. The patient engages in physical activity 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 Note: Physical activity level may be based on documentation or patient reporting. 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 13. Vaccinated for COVID-19, pneumococcus, and influenza (per European Union and Member 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 where the volume of targeted subsegments must meet the minimum Targeted Procedure Volume (TPV), with the total targeted volume allowing for two (2) ETLA procedures. Eligible subsegments are defined as having = 25% destruction %-950 HU per QCT analysis with a heterogeneity index (HI) >1.2. Note: Chest CT analysis by QCT Core Lab
Exclusion criteria
Exclusion criteria: 1. Body mass index (BMI) < 16 kg/m2 or = 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 (2) 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 Note: Measurements from right heart catheterizations are considered definitive over echocardiography. Patients with a pulmonary hypertension diagnosis must have an echocardiogram or right heart catheterization within the past 12 months 9. Alpha-1 antitrypsin deficiency 10. Uncontrolled diabetes mellitus with an HbA1c >9.0% within 6 months of enrollment Note: Patients with a diagnosis of diabetes mellitus must have an HbA1c measurement within the past 6 months. 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. Note: Patients with a heart failure diagnosis must have an LVEF measurement within the past 12 months 14. Heart failure requiring hospitalization, within 6 months prior to enrollment 15. History of bleeding disorders or enhanced predisposition to bleeding 16. History of hemoptysis with >200ml of blood loss in <24 hours 17. 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 18. Daily systemic steroids equivalent to > 15 mg prednisolone 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 who 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 study assessments and procedures, including bronchoscopy 25. Active aspergillus infection, including chronic aspergillus infection, aspergilloma, invasive aspergillosis, cavitation and/or history of aspergillus cavitatio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints will assess the feasibility and safety of ETLA.Feasibility:%of procedures where the device operated as intended per IFU% of procedures and % of target regions where saline is delivered at the predetermined volume per treatment planSafety:Incidence of serious adverse events (SAE) associated with the ETLA device and/or procedure through 9 months post-procedure 1 as adjudicated by an independent medical monitor | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints will assess the efficacy, feasibility, and safety of ETLA.Feasibility: • 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) at the below time points: o 3 months post-procedure 1 compared to baseline o 3 months post-procedure 2 compared to the scan at 3 months post-procedure 1 • Cumulative Lobar Volume Reduction as measured by CT scan, quantified by the summation of TLVR through both procedures (reported in ml)Safety: • Incidence of all adverse events associated with the ETLA device and/or procedure through 9 months post-procedure 1Efficacy: The following endpoints will be compared to baseline at 3 months and 9 months post-procedure 1 and 3 months post-procedure 2. • RV change (ml, % change in absolute and % predicted) • FEV1 change (ml, % change in absolute and % predicted) • 6MWT changes • SGRQ-C change | — |
Countries
Germany, Netherlands
Contacts
Public ContactD.J. Slebos
Universitair Medisch Centrum Groningen
Outcome results
None listed