Trial record 1 of 1 for:
Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study
This study is currently recruiting participants.
Verified December 2012 by PneumRx, Inc.
Information provided by (Responsible Party):
First received: May 26, 2012
Last updated: December 5, 2013
Last verified: December 2012
Multicenter, randomized, assessor-blinded controlled study of safety and effectiveness of the PneumRx, Inc. RePneu Lung Volume Reduction Coil (RePneu LVRC) System
Device: RePneu Lung Volume Reduction Coil System
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Mean absolute difference in SGRQ, 6MWT (responder analysis) and mean percent change in FEV1 comparing BL to 12 months, between Treatment arms. [ Time Frame: BL to 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||September 2014 (Final data collection date for primary outcome measure)
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.
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.
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.
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.
|Ages Eligible for Study:
||35 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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 225%
- 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.
- 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.
- 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 Nickel.
- Subject has a known sensitivity to drugs required to perform bronchoscopy.
- Subject has been diagnosed with alpha-1 antitrypsin deficiency (AATD).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01608490
||Charlie Strange, MD
||Medical University of South Carolina
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 26, 2012
||December 5, 2013
||United States: Food and Drug Administration
Keywords provided by PneumRx, Inc.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 11, 2013
Respiratory Tract Diseases