Patients with severe emphysema have limited options for treatment. Current treatments include lung transplant, lung volume reduction surgery or endobronchial lung volume reduction using valves or coils. These options are only available for a small and selected group of patients. The Free Flow Medical Lung Tensioning Device System (LTD) is thought to be the next generation endobronchial treatment for patients with severe emphysema designed to address this unmet need. The LTD is designed to compress the areas of lung parenchyma most damaged by emphysema and to tension surrounding tissue to help restore lung elastic recoil in a similar manner to the lung volume reduction coils.
Who can participate
Age range40 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Diagnosis of COPD
✓. FEV1/FVC ≤ 70%
✓. ≥ 40 years of age
✓. Post-bronchodilator FEV1 ≤ 45% of predicted
✓. Total Lung Capacity \> 100% of predicted
✓. Residual Volume (RV) \> 175% of predicted
✓. RV/TLC \> 55%
✓. Marked dyspnea defined by a score of ≥ 2 on mMRC dyspnea scale of 0-4
Exclusion criteria
✕. History of recurrent clinically significant respiratory infections and/or COPD exacerbations, defined as ≥ 2 hospitalizations for respiratory infections and/or COPD exacerbations during the year prior to enrolment
✕. History of recurrent clinically significant respiratory infections and/or COPD exacerbations, defined as ≥ 3 courses of prednisolone and/or antibiotics for respiratory infections and/or COPD exacerbations during the year prior to enrolment
What they're measuring
1
Safety: type and frequency of device-related and procedure-related AE
✕. Severe gas exchange abnormalities defined by PaCO2 \> 7.0 kPa (52 mmHg) and/or PaO2 \< 7.0 kPa (52 mmHg) (measured on room air)
✕. ≥ 10 mg prednisone (or equivalent dose of other corticosteroids) daily
✕. Inability to walk \> 140 meters in 6 minutes
✕. Known pulmonary hypertension defined by right ventricular systolic pressure \> 45 mmHg and/or evidence of pulmonary hypertension of right ventricular failure on echocardiogram