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LVRC IDE Crossover Study (Crossover From IDE Trial CLN0009) (CROSSOVER)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
PneumRx, Inc.
ClinicalTrials.gov Identifier:
NCT02059057
First received: February 6, 2014
Last updated: November 7, 2014
Last verified: January 2014
  Purpose

Crossover study for patients who were randomized to the Control Group in CLN0009.


Condition Intervention Phase
Emphysema
Device: LVRC System
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Crossover From IDE Trial CLN0009, Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study, IDE G110066

Resource links provided by NLM:


Further study details as provided by PneumRx, Inc.:

Primary Outcome Measures:
  • Difference from Baseline to 12 months in 6 MWT in cross over subjects from CLN0009 study. [ Time Frame: Up to 5 years post procedure ] [ Designated as safety issue: Yes ]
    This study provides the LVRC procedure to qualifying subjects who were enrolled as Control Subjects in and completed the Lung Volume Reduction Coil Treatment in Patients with Emphysema (RENEW) Study, CLN0009. As stated above the study will measure the Difference from Baseline to 12 months in 6 MWT.


Estimated Enrollment: 150
Study Start Date: January 2014
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LVRC System Device: LVRC System

Detailed Description:

Provide LVRC procedure to qualifying subjects who were enrolled as Control Subjects in and completed the Lung Volume Reduction Coil Treatment in Patients with Emphysema (RENEW) Study, CLN0009, and obtain safety and effectiveness data on these patients.

  Eligibility

Ages Eligible for Study:   36 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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 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 Nickel.
  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.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02059057

  Show 26 Study Locations
Sponsors and Collaborators
PneumRx, Inc.
  More Information

No publications provided

Responsible Party: PneumRx, Inc.
ClinicalTrials.gov Identifier: NCT02059057     History of Changes
Other Study ID Numbers: CLN0016
Study First Received: February 6, 2014
Last Updated: November 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Lung Diseases
Lung Diseases, Obstructive
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 27, 2014