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

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

1. Diagnosis of COPD
2. >= 40 years of age
3. FEV1/FVC <= 70%
4. Post-bronchodilator FEV1 <= 45% of predicted
5. Total Lung Capacity > 100% of predicted
6. Residual Volume (RV) > 175% of predicted
7. RV/TLC > 55%
8. Marked dyspnea defined by a score of >= 2 on mMRC dyspnea scale of 0-4
9. Emphysema with >= 20% destruction (-950HU) of one or more lobe(s)
10. Stopped smoking for >= 6 months prior to entering the study
11. Completed a pulmonary rehabilitation program prior to entering the study
and/or have regular (at least once a week) physiotherapy
12. Ability to read, understand and sign the informed consent form

Exclusion Criteria

1. 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
2. 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
3. Clinically significant bronchiectasis
4. Severe gas exchange abnormalities defined by PaCO2 > 7.0 kPa (52 mmHg)
and/or PaO2 < 7.0 kPa (52 mmHg) (measured on room air)
5. >= 10 mg prednisone (or equivalent dose of other corticosteroids) daily
6. Inability to walk > 140 meters in 6 minutes
7. Known pulmonary hypertension defined by right ventricular systolic pressure
> 45 mmHg and/or evidence of pulmonary hypertension or right ventricular
failure on echocardiogram
8. Significant paraseptal emphysema
9. Giant bullae (>1/3 of lung volume)
10. Medical history of asthma
11. Underwent previous LVRS, lobectomy, pneumonectomy or lung transplant
12. Underwent previous treatment with thermal vapor ablation, AeriSeal,
Cryospray, endobronchial coils or endobronchial valves (if still implanted)
13. Evidence of other disease(s) that have a predicted survival of less than
one year
14. Inability to tolerate bronchoscopy under general anaesthesia
15. 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
16. Pregnant, lactating or plans to become pregnant within the study timeframe
17. Known sensitivity to drugs required to perform bronchoscopy under general
anaesthesia
18. Any other disease(s), condition(s) or habit(s) that would interfere with
completion of study and follow up assessments, would increase the risks of
bronchoscopy or assessments or in the judgment of the investigator would
potentially interfere with the treatment
19. Known Nickel, Titanium, or Nitinol allergy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1) To evaluate the safety of the LTD in COPD patients with heterogeneous and<br /><br>homogeneous emphysema by evaluating the type and frequency of device-related<br /><br>and procedure-related AE experienced during and following LTD placement through<br /><br>the 3-month visit.<br /><br>2) To evaluate the feasibility of the LTD in COPD patients with heterogeneous<br /><br>and homogeneous emphysema by measuring the frequencies of successful and<br /><br>unsuccessful intended LTD placements. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) To investigate the change between baseline and 3 month follow up after LTD<br /><br>treatment in:<br /><br>- Patient reported symptoms using dedicated questionnaires (SGRQ, mMRC, CAT)<br /><br>- Pulmonary function outcomes:<br /><br>- 6 minute walking distance (6MWD)<br /><br>- Change in treatment target lobar volume on HRCT<br /><br>- Percentage of patients reaching the minimal important difference for: FEV1,<br /><br>RV, 6MWD, SGRQ</p><br>