Status:
COMPLETED
Study of PneumRx Endobronchial Coil System in Treatment of Subjects With Severe Emphysema
Lead Sponsor:
Boston Scientific Corporation
Collaborating Sponsors:
PneumRx, Inc.
Conditions:
Emphysema
Eligibility:
All Genders
35+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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 security.
Exclusion
- 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 significant pulmonary fibrosis
- Clinically significant, generalized bronchiectasis
- Clinically significant bleeding disorders
- Patient taking immunosuppressive 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 "personnel vulnerable" as defined by French Regulation
Key Trial Info
Start Date :
May 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 22 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03360396
Start Date
May 7 2018
End Date
November 22 2022
Last Update
August 28 2023
Active Locations (19)
Enter a location and click search to find clinical trials sorted by distance.
1
Ludwig Boltzmann Institut Fur COPD und pneumologische Epidemologie
Vienna, Austria
2
CHU Grenoble
Grenoble, France
3
CHU Montpellier
Montpellier, France
4
Centre Hospitalier Universitaire de Nice
Nice, France, CS 51069