LVRC IDE Crossover Study (Crossover From IDE Trial CLN0009)
NCT ID: NCT02059057
Last Updated: 2021-07-19
Study Results
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View full resultsBasic Information
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TERMINATED
NA
102 participants
INTERVENTIONAL
2013-12-31
2019-07-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LVRC System
LVRC System
Interventions
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LVRC System
Eligibility Criteria
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Inclusion Criteria
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
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.
\-
36 Years
ALL
No
Sponsors
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PneumRx, Inc.
INDUSTRY
Boston Scientific Corporation
INDUSTRY
Responsible Party
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Locations
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University of Alabama Lung Health Center
Birmingham, Alabama, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
El Camino Hospital/Palo Alto Medical Foundation
Mountain View, California, United States
Yale University School of Medicine - Yale New Haven Hospital
New Haven, Connecticut, United States
University of Florida
Gainesville, Florida, United States
Northwestern University
Chicago, Illinois, United States
Illinois Lung and Critical Care Institute
Peoria, Illinois, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
New York Presbyterian Columbia University Medical Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
The Cleveland Clinic
Cleveland, Ohio, United States
Temple
Philadelphia, Pennsylvania, United States
Emphysema COPD Research Center, University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Pulmonary, Critical Care & Sleep Medicine Consultants,PCCS/St. Luke's Episcopal Hospital
Houston, Texas, United States
University of Texas Health Sciences Center at San Antonio
San Antonio, Texas, United States
Franciscan Research Center
Tacoma, Washington, United States
University of Wisconsin School of Medicine & Public Health
Madison, Wisconsin, United States
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
Québec, , Canada
Centre Hospitalier Universitaire de Nice
Nice, , France
CHU de Reims - Hopital Maison Blanche
Reims, , France
University Medical Center Groningen
Groningen, , Netherlands
Royal Brompton Hospital & Chelsea Westminster
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CLN0016
Identifier Type: -
Identifier Source: org_study_id
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