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Trial record 1 of 1 for:    NCT01608490
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Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study (RENEW)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01608490
First Posted: May 31, 2012
Last Update Posted: June 27, 2017
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.
Information provided by (Responsible Party):
PneumRx, Inc.
May 26, 2012
May 31, 2012
April 25, 2017
June 27, 2017
June 27, 2017
October 2012
December 2015   (Final data collection date for primary outcome measure)
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
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 ]
Complete list of historical versions of study NCT01608490 on ClinicalTrials.gov Archive Site
Mean Percent Change in FEV1 [ Time Frame: BL to 12 months ]
Mean percent change in FEV1 at 12 months
St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: BL to 12 months ]
Not Provided
Not Provided
 
Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study
Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study
Multicenter, randomized, assessor-blinded controlled study of safety and effectiveness of the PneumRx, Inc. RePneu Lung Volume Reduction Coil (RePneu LVRC) System
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.
Interventional
Not Provided
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
Emphysema
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.
  • 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.
Sciurba FC, Criner GJ, Strange C, Shah PL, Michaud G, Connolly TA, Deslée G, Tillis WP, Delage A, Marquette CH, Krishna G, Kalhan R, Ferguson JS, Jantz M, Maldonado F, McKenna R, Majid A, Rai N, Gay S, Dransfield MT, Angel L, Maxfield R, Herth FJ, Wahidi MM, Mehta A, Slebos DJ; RENEW Study Research Group. Effect of Endobronchial Coils vs Usual Care on Exercise Tolerance in Patients With Severe Emphysema: The RENEW Randomized Clinical Trial. JAMA. 2016 May 24-31;315(20):2178-89. doi: 10.1001/jama.2016.6261.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
315
March 2020
December 2015   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
35 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   France,   Germany,   Netherlands,   United Kingdom,   United States
 
 
NCT01608490
CLN0009
Yes
Not Provided
Plan to Share IPD: Undecided
PneumRx, Inc.
PneumRx, Inc.
Not Provided
Principal Investigator: Charlie Strange, MD Medical University of South Carolina
PneumRx, Inc.
April 2017

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