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

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: NCT03360396
Recruitment Status : Active, not recruiting
First Posted : December 4, 2017
Last Update Posted : February 1, 2021
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
PneumRx, Inc.

Study Description
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Brief Summary:
This study will look at outcomes between Endobronchial Coil Treatment and Control groups in patients with severe heterogeneous and or homogeneous emphysema.

Condition or disease Intervention/treatment Phase
Emphysema Device: Endobronchial Coils Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study of PneumRx Endobronchial Coil System Versus Standard-of-Care Medical Management in the Treatment of Subjects With Severe Emphysema
Actual Study Start Date : May 7, 2018
Actual Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema

Arms and Interventions
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Arm Intervention/treatment
Experimental: Endobronchial Coils
Treatment with PneumRx Endobronchial Coil System
 Device: Endobronchial Coils
Endobronchial Coil implants
No Intervention: Control
Medically-managed control group


Outcome Measures
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Primary Outcome Measures :
  1. FEV1 [ Time Frame: 6 months ]
    Percent change in FEV1

  2. SGRQ [ Time Frame: 6 months ]
    Change in SGRQ score


Eligibility Criteria
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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  • if treated in France, subject must be entitled to French social securty.

Exclusion Criteria:

  • Known sensitivity to drugs required for performing bronchoscopy or in whom bronchoscopic procedures are contraindicated
  • Evidence of active infection in the lungs
  • Hypersensitivity or allergy to nitinol (nickel-titanium) or its constituent metals
  • Clinical significatne pulmonary fibrosis
  • Clinically significant, generalized bronchiectasis
  • Clinically significant bleeding disorders
  • Patient taking immunosuppresive drugs other than steroids (e.g., for the treatment of cancer, rheumatoid arthritis, autoimmune disease, or prevention of tissue or organ rejection).
  • 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
  • Severe bullous disease (defined by bulla > 8cm or 1/3 of lung volume, or single bullous defect >8 cm) or predominant paraseptal emphysema [defined by numerous large (>1cm) paraseptal defects in the target lobe comprising of >5% of total lung volume].
  • 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 20 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
  • Diffusion Capacity of the lUngs for Carbon Monoxide (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
  • Participation in any other clinical Study.
  • Subject is pregnant or lactating, or plan to become pregnant within the study timeframe.
  • If treated in France, Subject is a "personne vulnerable" as defined by French Regulation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03360396


Locations
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Sponsors and Collaborators
PneumRx, Inc.
Boston Scientific Corporation
Investigators
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Principal Investigator: Felix Herth, MD, University Hospital Heidelberg
Principal Investigator: Arschang Valipour, MD,FCCP,PhD Nord-Klinik Floridsdorf
More Information
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Responsible Party: PneumRx, Inc.
ClinicalTrials.gov Identifier: NCT03360396    
Other Study ID Numbers: BTG-004517-01
First Posted: December 4, 2017    Key Record Dates
Last Update Posted: February 1, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by PneumRx, Inc.:
severe heterogeneous emphysema
severe homogeneous emphysema
Additional relevant MeSH terms:
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Pulmonary Emphysema
Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
 Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases