EFFORT: Evaluation of the Free Flow Medical Lung Tensioning Device System for the Treatment of Severe Emphysema
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment group Bronchoscopic LTD placement |
Device: FreeFlowMedical Lung Tensioning Device
Bronchoscopic lung tensioning device implantation
|
Outcome Measures
Primary Outcome Measures
- Safety: type and frequency of device-related and procedure-related AE [3 months]
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.
- Procedural succes [3 months]
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.
Secondary Outcome Measures
- Performance - Quality of Life: St George's Respiratory Questionnaire [3 months]
Change in St George's Respiratory Questionnaire total score
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosis of COPD
-
FEV1/FVC ≤ 70%
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≥ 40 years of age
-
Post-bronchodilator FEV1 ≤ 45% of predicted
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Total Lung Capacity > 100% of predicted
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Residual Volume (RV) > 175% of predicted
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RV/TLC > 55%
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Marked dyspnea defined by a score of ≥ 2 on mMRC dyspnea scale of 0-4
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Emphysema with ≥ 20% destruction (on -950 Hounsfield units) of two potential treatment lobe(s)
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Stopped smoking for ≥ 6 months prior to entering the study
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Completed a pulmonary rehabilitation program prior to entering the study and/or have regular (at least once a week) physiotherapy
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Ability to read, understand and sign the informed consent form
Exclusion Criteria:
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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
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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
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Clinically significant bronchiectasis
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Severe gas exchange abnormalities defined by PaCO2 > 7.0 kPa (52 mmHg) and/or PaO2 < 7.0 kPa (52 mmHg) (measured on room air)
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≥ 10 mg prednisone (or equivalent dose of other corticosteroids) daily
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Inability to walk > 140 meters in 6 minutes
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Known pulmonary hypertension defined by right ventricular systolic pressure > 45 mmHg and/or evidence of pulmonary hypertension of right ventricular failure on echocardiogram
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Significant paraseptal emphysema
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Giant bullae (>1/3 of lung volume)
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Medical history of asthma
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Underwent previous LVRS, lobectomy, pneumonectomy or lung transplant
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Underwent previous treatment with thermal vapor ablation, AeriSeal, Cryospray, endobronchial coils or endobronchial valves (if still implanted)
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Evidence of other disease(s) that have a predicted survival of less than one year
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Inability to tolerate bronchoscopy under general anaesthesia
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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
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Pregnant, lactating or plans to become pregnant within the study timeframe
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Known sensitivity to drugs required to perform bronchoscopy under general anaesthesia
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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
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Known Nickel, Titanium, or Nitinol allergy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dept. of Pneumology and Critical Care Medicine, Thoraxklinik, University of Heidelberg | Heidelberg | Baden-Württemberg | Germany | D-69126 |
| 2 | University Medical Center Groningen | Groningen | Netherlands | 9700RB |
Sponsors and Collaborators
- University Medical Center Groningen
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EFFORT