Evaluation of the Free Flow Medical Lung Tensioning Device System for the Treatment of Severe Emphysema

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Free Flow Medical Lung Tensioning Device System for the Treatment of Severe Emphysema - EFFORT

Conditions
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Emphysema or COPD

Intervention / Treatment
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* Device: FreeFlowMedical Lung Tensioning Device


Participation Criteria
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Eligibility Criteria
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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 Emphysema with ≥ 20% destruction (on -950 Hounsfield units) of two potential treatment lobe(s) Stopped smoking for ≥ 6 months prior to entering the study Completed a pulmonary rehabilitation program prior to entering the study and/or have regular (at least once a week) physiotherapy Ability to read, understand and sign the informed consent form 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 Clinically significant bronchiectasis 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 Significant paraseptal emphysema Giant bullae (>1/3 of lung volume) Medical history of asthma Underwent previous LVRS, lobectomy, pneumonectomy or lung transplant Underwent previous treatment with thermal vapor ablation, AeriSeal, Cryospray, endobronchial coils or endobronchial valves (if still implanted) Evidence of other disease(s) that have a predicted survival of less than one year Inability to tolerate bronchoscopy under general anaesthesia Maintenance antiplatelet (except aspirin/Ascal) or anticoagulant therapy (such as warfarin, Coumadin, heparin, LMWH, DOACs, etc) which cannot be permanently stopped prior to entering the study Pregnant, lactating or plans to become pregnant within the study timeframe Known sensitivity to drugs required to perform bronchoscopy under general anaesthesia Any other disease, condition(s) or habit(s) that would interfere with completion of study and follow up assessments, would increase risks of bronchoscopy or assessments or in the judgment of the investigator would potentially interfere Known Nickel, Titanium, or Nitinol allergy

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Bronchoscopic LTD placement | Device: FreeFlowMedical Lung Tensioning Device<br>* Bronchoscopic lung tensioning device implantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: type and frequency of device-related and procedure-related AE | To evaluate the safety of the LTD in COPD patients with heterogeneous and homogeneous emphysema by evaluating the type and frequency of device-related and procedure-related AE experienced during and following LTD placement through the 3-month visit. | 3 months | 
| Procedural succes | To evaluate the feasibility of the LTD in COPD patients with heterogeneous and homogeneous emphysema by measuring the frequencies of successful and unsuccessful intended LTD placements. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance - Quality of Life: St George's Respiratory Questionnaire | Change in St George's Respiratory Questionnaire total score | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung volume reduction, nitinol, device