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Study of PneumRx Endobronchial Coil System in Treatment of Subjects With Severe Emphysema (ELEVATE)

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ClinicalTrials.gov Identifier: NCT03360396
Recruitment Status : Recruiting
First Posted : December 4, 2017
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
PneumRx, Inc.

Tracking Information
First Submitted Date  ICMJE November 22, 2017
First Posted Date  ICMJE December 4, 2017
Last Update Posted Date May 31, 2019
Actual Study Start Date  ICMJE May 7, 2018
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 27, 2017)
  • FEV1 [ Time Frame: 6 months ]
    Percent change in FEV1
  • SGRQ [ Time Frame: 6 months ]
    Change in SGRQ score
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03360396 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2017)
  • Responder Rate [ Time Frame: 6 months ]
    percent change in subjects who achieve two or more MCIDs (6MWT >=26 meters, SGRQ <= -4 points, RV >=350 ml, FEV1 >=10%
  • Mean Expiratory Lobar Volume [ Time Frame: 6 months ]
    change in mean expiratory lobar volume of treated lobes
  • VC [ Time Frame: 6 months ]
    Change in vital capacity
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 27, 2017)
  • Pulmonary Function - RV [ Time Frame: 6 months ]
    RV
  • Pulmonary Function - RV/TLC [ Time Frame: 6 months ]
    RV/TLC
  • Pulmonary Function - FEV` [ Time Frame: 6 months ]
    FEV1
  • Pulmonary Function FEV1/FVC [ Time Frame: 6 months ]
    FEV1/FVC
  • 6MWT [ Time Frame: 6 months ]
    change in exercise capacity (6MWT)
  • CAT [ Time Frame: 6 months ]
    change in CAT
  • EQ-5D [ Time Frame: 6 months ]
    change in EQ-5D
  • Individual MCID responder rates 6MWT [ Time Frame: 6 months ]
    6MWT
  • Individual MCID responder rates FEV1 [ Time Frame: 6 months ]
    FEV1
  • Individual MCID responder rates SGRQ [ Time Frame: 6 months ]
    SGRQ
  • responder rate of FEV1 [ Time Frame: 6 months ]
    responder rate defined as percent of subjects who achieve FEV1 change >= 12%
  • SGRQ responder rate [ Time Frame: 6 months ]
    responder rate defined as percent of subjects that achieve SGRQ <= -8 points
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Study of PneumRx Endobronchial Coil System in Treatment of Subjects With Severe Emphysema
Official Title  ICMJE A Randomized Controlled Study of PneumRx Endobronchial Coil System Versus Standard-of-Care Medical Management in the Treatment of Subjects With Severe Emphysema
Brief Summary This study will look at outcomes between Endobronchial Coil Treatment and Control groups in patients with severe heterogeneous and or homogeneous emphysema.
Detailed Description This will be a prospective, multicenter, randomized, controlled study comparing outcomes between the Endobronchial Coil and Control Groups. Subjects will be block randomized in a Treatment to Control ratio of 2:1. The randomization will be stratified by site and homogeneous versus heterogeneous emphysema, to support a balance of patients with differing heterogeneity in both the Treatment and Control Groups
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Emphysema
Intervention  ICMJE Device: Endobronchial Coils
Endobronchial Coil implants
Study Arms  ICMJE
  • Experimental: Endobronchial Coils
    Treatment with PneumRx Endobronchial Coil System
    Intervention: Device: Endobronchial Coils
  • No Intervention: Control
    Medically-managed control group
Publications * Not Provided

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 27, 2017)
210
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Read, understood and signed the Informed Consent form
  • Meets indications for use per the IFU
  • Bilateral heterogeneous and/or homogeneous emphysema
  • Post bronchodilator 15% predicted ≤ Forced Expiratory Volume in 1 second (FEV1) ≤ 45% predicted
  • Post bronchodilator Residual Volume (RV) ≥ 200% predicted
  • Post bronchodilator Total Lung Capacity (TLC) >100% pred.
  • Post bronchodilator RV/TLC > 55%
  • Dyspnea related to hyperinflation scored ≥ 2 on modified Medical Research Council (mMRC) dyspnea scale despite optimal medical management
  • Receiving optimal drug therapy and medical management according to clinical practice.
  • Performing regular physical activity, at least 2 times per week
  • Stopped smoking as confirmed by carboxyhemoglobin (CoHB)
  • 100m ≤ 6 minute walk distance (6MWD) ≤ 450m
  • Deemed eligible per Eligibility Review Committee (ERC)

Exclusion Criteria:

  • Meets any of the contraindications listed in the IFU
  • Primary diagnosis of asthma
  • Two (2) or more COPD exacerbations in the prior year, or 1 or more COPD exacerbations in the prior 3 months with indication for hospitalization assessment, according to GOLD 2017 recommendations .
  • Predominant small airways disease defined as significant bronchiectasis with sputum production (> 2 tablespoons daily) or significant bronchial wall thickening per High Resolution Computed Tomography (HRCT)
  • Percent Low Attenuation Area (%LAA) < 20% in the most damaged lobe of either lung.
  • Computed Tomography (CT) Imaging consistent with active pulmonary infection, significant interstitial disease or pleural disease (predominant bulla > 8cm or 1/3 hemithorax), or severe bullous or predominant paraseptal emphysema pattern
  • Lung pathology of nodule not proven stable or benign
  • Radiographic confirmation of atelectasis or other scarring/fibrosis in areas of intended Coil implant
  • Use of more than 10 mg/day prednisolone or equivalent dosage of a different corticosteroid
  • Severe pulmonary hypertension (Right Ventricular Systolic Pressure (RVSP) > 50 mm Hg or other signs of Pulmonary Hypertension (PHT) with right ventricular dysfunction)
  • Severe hypercapnia (PaCO2 > 55 mmHg on room air) and/or severe hypoxemia (PaO2 < 45mm Hg on room air, High altitude criterion: PaO2 < 30 mm Hg)
  • Previous Lung Volume Reduction (LVR) surgery, lung transplantation, lobectomy, LVR devices or other device to treat COPD in either lung.
  • Diagnosed with alpha-1 antitrypsin deficiency
  • DLCO < 20 %
  • Significant, recent or unstable cardiac disease defined as severe heart failure (Left Ventricular Ejection Fraction (LVEF) < 45% despite optimal medical management), unstable cardiac arrhythmia or coronary artery disease (angina on activity), or ischemic event in the past 6 months.
  • Body Mass Index (BMI) > 30
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Austria,   France,   Germany,   Italy,   Netherlands,   Switzerland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03360396
Other Study ID Numbers  ICMJE BTG-004517-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
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: Felix Herth, MD, University Hospital Heidelberg
Principal Investigator: Arschang Valipour, MD,FCCP,PhD Otto-Wagner-Spital
PRS Account PneumRx, Inc.
Verification Date May 2019

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