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Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study (RENEW)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01608490
Recruitment Status : Terminated (FDA approval of supplementation to IDE to terminate subject long term follow up)
First Posted : May 31, 2012
Results First Posted : June 27, 2017
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
PneumRx, Inc.

Tracking Information
First Submitted Date  ICMJE May 26, 2012
First Posted Date  ICMJE May 31, 2012
Results First Submitted Date  ICMJE April 25, 2017
Results First Posted Date  ICMJE June 27, 2017
Last Update Posted Date August 21, 2019
Study Start Date  ICMJE October 2012
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2017)
Meters: 6 Minute Walk Test [ Time Frame: baseline through 12 months follow up ]
mean absolute change from baseline at 12 months in the 6 Minute Walk Test comparing test and control groups
Original Primary Outcome Measures  ICMJE
 (submitted: May 30, 2012)
mean absolute change from baseline at 12 months in the 6 Minute Walk Test comparing test and control groups [ Time Frame: baseline through 12 months follow up ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2017)
Mean Percent Change in FEV1 [ Time Frame: BL to 12 months ]
Mean percent change in FEV1 at 12 months
Original Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2012)
St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: BL to 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study
Official Title  ICMJE Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study
Brief Summary Multicenter, randomized, assessor-blinded controlled study of safety and effectiveness of the PneumRx, Inc. RePneu Lung Volume Reduction Coil (RePneu LVRC) System
Detailed Description This will be a prospective, multicenter, randomized, controlled study comparing outcomes between the LVRC and Control Groups. Subjects will be block randomized in an LVRC (Treatment) to Control ratio of 1:1. The randomization will be stratified by homogeneous versus heterogeneous emphysema, to support a balance of patients with differing heterogeneity in both the LVRC and Control Groups.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
One group received standard of care and LVRC and the control group received only standard of care.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Emphysema
Intervention  ICMJE Device: RePneu Lung Volume Reduction Coil System
The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.
Study Arms  ICMJE
  • Experimental: RePneu Lung Volume Reduction Coil System
    The RePneu Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps.
    Intervention: Device: RePneu Lung Volume Reduction Coil System
  • No Intervention: Control arm is standard medical care
    The Control Group will not undergo any bronchoscopies for Coil placement and will not receive prophylactic antibiotics or steroids before and after 'treatment' or chest x-rays in connection with the 'treatment' visits. The frequency of visits to the Study Doctor or designee will be similar to the LVRC Group.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 30, 2012)
315
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 26, 2019
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject is greater than or equal to 35 yrs of age
  • CT Scan indicates bilateral emphysema
  • Subject has post-bronchodilator FEV1 less than or equal to 45% predicted
  • Subject has Total Lung Capacity >100% predicted
  • Subject has residual volume (RV) greater than or equal to 175% predicted
  • Subject has marked dyspnea greater than or equal to 2 on mMRC scale of 0-4
  • 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.
  • Subject has completed a pulmonary rehabilitation program within 6 mos prior to treatment and/or is regularly performing maintenance respiratory rehabilitation if initial supervised therapy occurred more than 6 mos prior to baseline testing.
  • Subject has received Pneumococcal and Influenza vaccinations consistent with local recommendations and/or policy.
  • Subject (and legal guardian, if applicable) has read, understood, and signed the Informed Consent form.

Exclusion Criteria:

  • Subject has severe homogeneous emphysema determined by Core Radiology Lab.
  • 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.
  • Subject has a change in FEV1 of greater than 20% (or, for subjects with pre-bronchodilator FEV1 below 1L, a change of greater than 200mL) post-bronchodilator unless investigator can confirm by other means that subject does not have asthma.
  • Subject has DLCO of less than 20% of predicted.
  • Subject has severe gas exchange abnormalities, PaCO2 of greater than 55mm Hg; PaO2 of less than 45 mm Hg on room air (high altitude criterion: PaO2 of less than 30mm Hg).
  • Subject has a history of recurrent clinically significant respiratory infections, defined as 3 hospitalizations for respiratory infection during the year prior to enrollment.
  • Subject as severe pulmonary hypertension defined by right ventricular systolic pressure of greater than 50mm Hg and/or echocardiogram
  • Subject has an inability to walk >140m (150 yd) in 6 minutes
  • 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.
  • Subject is pregnant or lactating, or plans to become pregnant within the study timeframe.
  • Subject has an inability to tolerate bronchoscopy under moderate sedation or general anesthesia.
  • Subject has clinically significant bronchiectasis.
  • Subject has giant bullae >1/3 lung volume
  • Subject has had previous LVR surgery, lung transplantation, lobectomy or LVR devices in either lung.
  • Subject has been involved in pulmonary drug or device studies within 30 days prior to this study.
  • Subject is taking >20mg prednisone (or equivalent dose of a similar steroid) daily.
  • Subject requires high level chronic immunomodulatory therapy to treat a moderate to severe chronic inflammatory autoimmune disorder.
  • Subject is on an antiplatelet agent (such as Plavix) or anticoagulant therapy (such as Heparin or Coumadin) which cannot be stopped for 7 days prior to the procedure.
  • 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.
  • Subject has a sensitivity or allergy to nitinol (nickel-titanium) or its constituent metals.
  • Subject has a known sensitivity to drugs required to perform bronchoscopy.
  • Subject has been diagnosed with alpha-1 antitrypsin deficiency (AATD).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   France,   Germany,   Netherlands,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01608490
Other Study ID Numbers  ICMJE CLN0009
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party PneumRx, Inc.
Study Sponsor  ICMJE PneumRx, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Charlie Strange, MD Medical University of South Carolina
PRS Account PneumRx, Inc.
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP