The safety and feasibility of re-treating patients with severe emphysema with the RePneu LVRC system: a pilot study.
- Conditions
- COPDemphysema10038716
- Registration Number
- NL-OMON38678
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
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.
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 < 6.0 kPa (room air).
3) Subject has a history of recurrent clinically significant respiratory infections, defined as 3 hospitalizations for respiratory infection during the year prior to enrollment.
4) Subject has severe pulmonary hypertension defined by right ventricular systolic pressure >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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The safety objective of this study is to identify the potential number and type<br /><br>of device-related and procedure-related adverse effects.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Lung function<br /><br>- Change in RV, 6 months following treatment<br /><br>- Change in RV/TLC ratio, 6 months following treatment<br /><br>- Changes in FEV1 and FVC, 2 and 6 months following treatment<br /><br>Quality of life<br /><br>- Change in the SGRQ score, 2 and 6 months following treatment<br /><br>- Change in the CCQ score, 2 and 6 months following treatment<br /><br>Functional measures<br /><br>- Change in the mMRC score, 2 and 6 months following treatment<br /><br>- Change in the 6MWD, 2 and 6 months following treatment</p><br>