Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-24 @ 6:55 PM
NCT ID:
NCT02059057
Eligibility Criteria:
Inclusion Criteria:
1. Subject was enrolled as a Control Subject in and completed all required study assessments through the 12 month visit for the Lung Volume Reduction Coil Treatment in Patients with Emphysema (RENEW) Study, CLN0009.
2. Subject has post-bronchodilator FEV1 ≤45% predicted.
3. Subject has residual volume (RV) ≥175% predicted.
4. Subject has stopped smoking for at least 8 weeks prior to entering the study, as confirmed by a Cotinine test or other appropriate diagnostic test.
5. Subject has read, understood and signed the Informed Consent form.
6. Subject has received Pneumococcal and Influenza vaccinations consistent with local recommendations and/or policy.
Exclusion Criteria:
1. Subject has severe homogeneous emphysema as determined by the Core Radiology Lab
2. 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.
3. Subject has a change in FEV1 \>20% (or, for subjects with pre-bronchodilator FEV1 below 1 L, a change of \> 200 mL) post-bronchodilator, unless investigator can confirm by other means that subject does not have asthma.
4. Subject has DLCO \<20% of predicted.
5. Subject has severe gas exchange abnormalities as defined by:
PaCO2 \>55 mm Hg PaO2 \<45 mm Hg on room air (High altitude criterion: PaO2 \<30 mm Hg)
6. Subject has a history of recurrent clinically significant respiratory infections, defined as 3 hospitalizations for respiratory infection during the year prior to enrollment.
7. Subject has severe pulmonary hypertension. If pulmonary hypertension is present, "severe" is defined by right ventricular systolic pressure \>50 mm Hg via right heart catheterization and/or echocardiogram.
8. Subject has an inability to walk \>140 meters (150 yards) in 6 minutes.
9. 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.
10. Subject is pregnant or lactating, or plans to become pregnant within the study timeframe.
11. Subject has an inability to tolerate bronchoscopy under moderate sedation or general anesthesia.
12. Subject has clinically significant bronchiectasis.
13. Subject has giant bullae \>1/3 lung volume.
14. Subject has had previous LVR surgery, lung transplantation, lobectomy, LVR devices or other devices to treat COPD in either lung.
15. Subject has been involved in pulmonary drug or device studies within 30 days prior to this study, with the exception of the RENEW Study.
16. Subject is taking \>20 mg prednisone (or equivalent dose of a similar steroid) daily.
17. Subject requires high level chronic immunomodulatory therapy to treat a moderate to severe chronic inflammatory autoimmune disorder.
18. Subject is on an antiplatelet agent (such as Plavix) or anticoagulant therapy (such as heparin or Coumadin) which cannot be stopped for seven (7) days prior to procedure.
19. Subject has a sensitivity or allergy to nitinol (nickel-titanium) or its constituent metals.
20. Subject has a known sensitivity to drugs required to perform bronchoscopy.
21. Subject has been diagnosed with alpha-1 antitrypsin deficiency (AATD).
22. 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 with compliance to this study or would adversely affect study outcomes.
\-
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
36 Years
Study:
NCT02059057
Study Brief:
Protocol Section:
NCT02059057