COPD emphysema
Conditions
Interventions
Patients will receive a lung volume reduction coil treatment by bronchoscopy.
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Treated with the RePneu LVRC system > 24 months ago. 2) Six months after the first bilateral treatment with the RePneu LVRC system the patient had a significant improvement above the established minimal important difference (MID) of 6-minute walk distance (6MWD: 26 meter) or of forced expiratory volume in 1 second (FEV1: 100ml) or of St. Georges Respiratory Questionnaire total score (SGRQ: 4 points). 3) Subject has marked dyspnea scoring >=2 on mMRC scale of 0-4. 4) Subject has stopped smoking for at least 6 months prior to entering the study. 5) Subject read, understood and signed the Informed Consent form. 6) Subject has completed a pulmonary rehabilitation program within 6 months prior to treatment and/or regularly performing maintenance respiratory rehabilitation if initial supervised therapy occurred more than 6 months prior to baseline testing. 7) Subject has received Influenza vaccinations consistent with local recommendations and/or policy.
Exclusion criteria
Exclusion criteria: 1) Subject has co-morbidities that may significantly reduce subject*s ability to improve exercise capacity (e.g., severe arthritis, planned knee surgery) or baseline limitation on 6MWT is not due to dyspnea. 2) Subject has severe gas exchange abnormalities as defined by: PaCO2 >8.0 kPa; PaO2 50 mm Hg via echocardiogram. 5) Subject has an inability to walk >140 meters in 6 minutes. 6) Subject has evidence of other severe disease (such as, but not limited to, lung cancer or renal failure), which in the judgment of the investigator may compromise survival of the subject for the duration of the study. 7) Subject is pregnant or lactating, or plans to become pregnant within the study timeframe. 8) Subject has an inability to tolerate bronchoscopy under moderate sedation or general anesthesia. 9) Subject has clinically significant bronchiectasis. 10) Subject has giant bullae >1/3 lung volume. 11) Subject has had previous LVR surgery, lung transplantation or lobectomy. 12) Subject has been involved in pulmonary drug or device studies within 30 days prior to this study. 13) Subject is taking >20 mg prednisone (or equivalent dose of a similar steroid) daily. 14) Subject requires high level chronic immunomodulatory therapy to treat a moderate to severe chronic inflammatory autoimmune disorder. 15) Subject is on an antiplatelet (such as Plavix) or anticoagulant therapy (such as heparin or Coumadin) which cannot be stopped for 7 days prior to procedure. 16) Subject has a sensitivity or allergy to Nickel. 17) Subject has a known sensitivity to drugs required to perform bronchoscopy. 18) Subject has 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety objective of this study is to identify the potential number and type of device-related and procedure-related adverse effects. | — |
Secondary
| Measure | Time frame |
|---|---|
| Lung function - Change in RV, 6 months following treatment - Change in RV/TLC ratio, 6 months following treatment - Changes in FEV1 and FVC, 2 and 6 months following treatment Quality of life - Change in the SGRQ score, 2 and 6 months following treatment - Change in the CCQ score, 2 and 6 months following treatment Functional measures - Change in the mMRC score, 2 and 6 months following treatment - Change in the 6MWD, 2 and 6 months following treatment | — |
Countries
Netherlands
Outcome results
None listed