EmphysemaELEVATENCT03360396
Study of PneumRx Endobronchial Coil System in Treatment of Subjects With Severe Emphysema
A study testing Endobronchial Coils in people with Emphysema, run by Boston Scientific Corporation at 19 sites in 6 countries.
Trial summary
This study will look at outcomes between Endobronchial Coil Treatment and Control groups in patients with severe heterogeneous and or homogeneous emphysema. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Emphysema
- What is being tested?
- Endobronchial Coils
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 19 sitesin 6 countries
- Study dates
- 7 May 2018to 22 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
19 sites in 6 countries.
19 sites in 6 countries
Germany9 sites
Charite Berlin - Medizinische Klinik mit Schwerpunkt Infektiologie und Pneumologie
Berlin
Gemeinschaftskrankenhaus Havelhöhe GmbH
Berlin
Universitätsklinkum Bonn
Bonn
Ruhrlandklinik Essen
Essen
Thoraxklinik
Heidelberg
Lungenklinik
Hemer
Lungenfachklinik Immenhausen
Immenhausen, 34376
Klinikverbund Kempten-Oberallgäu
Immenstädt
Krankenhaus vom Roten Kreuz Bad Cannstatt GmbH
Stuttgart
France6 sites
CHU Grenoble
Grenoble
CHU Montpellier
Montpellier
Centre Hospitalier Universitaire de Nice
Nice, CS 51069
Hôpital Bichat
Paris
CHU de Reims - Hopital Maison Blanche
Reims, 51092
Nouvel Hôpital Civil
Strasbourg, 67091
Austria1 site
Ludwig Boltzmann Institut Fur COPD und pneumologische Epidemologie
Vienna
Netherlands1 site
University Medical Center Groningen
Groningen, 3150-3610536
About this study
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
This study will look at outcomes between Endobronchial Coil Treatment and Control groups in patients with severe heterogeneous and or homogeneous emphysema.
Read the 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
- Conditions
- Emphysema
- Being tested
- Endobronchial Coils
- Keywords
- severe heterogeneous emphysema, severe homogeneous emphysema
- Medical subject headings
- Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endobronchial CoilsDevice
Endobronchial Coil implants
| Study group | Role | What they receive |
|---|---|---|
| Endobronchial Coils | Experimental | Treatment with PneumRx Endobronchial Coil System Receives: Device: Endobronchial Coils |
| Control | No intervention | Medically-managed control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in FEV1 at 6 Months
Percent change in FEV1
Measured: 6 months
Absolute Change in SGRQ Score at 6 Months
Change in SGRQ score - St. George Respiratory Questionnaire from 0 to 100, higher score indicating more limitations (worse), increase in score indicating worse outcome, decrease in score indicating improvement
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start7 May 2018
- Primary completion26 Feb 2020
- Study completion22 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EmphysemaStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PneumRx, Inc.
- Responsible party
- Sponsor
- Investigators
- Felix Herth, MD,, Principal investigator, University Hospital HeidelbergArschang Valipour, MD,FCCP,PhD, Principal investigator, Nord-Klinik Floridsdorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03360396
- Sponsor's protocol ID
- BTG-004517-01
- Acronym
- ELEVATE
- Status last verified
- Aug 2023
- First submitted
- 22 Nov 2017
- Last updated
- 28 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Agrawal A. Interventional Pulmonology: Diagnostic and Therapeutic Advances in Bronchoscopy. Am J Ther. 2021 Feb 9;28(2):e204-e216. doi: 10.1097/MJT.0000000000001344.
PubMed 33590989
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03360396
- Acronym / sponsor ID
- ELEVATE / BTG-004517-01
- Conditions
- Emphysema
- Keywords
- severe heterogeneous emphysema, severe homogeneous emphysema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Collaborators
- PneumRx, Inc.
- Study start
- 7 May 2018 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 22 Nov 2022 (actual)
- First posted
- 4 Dec 2017 (actual)
- Results
- Posted 3 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endobronchial Coils | Experimental | Device: Endobronchial CoilsTreatment with PneumRx Endobronchial Coil System |
| Control | No intervention | –Medically-managed control group |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endobronchial CoilsEndobronchial Coil implants | Device | Endobronchial Coils |
Primary outcome
Percent Change in FEV1 at 6 Months
Time frame: 6 months
Percent change in FEV1
Absolute Change in SGRQ Score at 6 Months
Time frame: 6 months
Change in SGRQ score - St. George Respiratory Questionnaire from 0 to 100, higher score indicating more limitations (worse), increase in score indicating worse outcome, decrease in score indicating improvement
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33590989Agrawal A. Interventional Pulmonology: Diagnostic and Therapeutic Advances in Bronchoscopy. Am J Ther. 2021 Feb 9;28(2):e204-e216. doi: 10.1097/MJT.0000000000001344.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felix Herth, MD, principal investigator
University Hospital Heidelberg
Arschang Valipour, MD,FCCP,PhD principal investigator
Nord-Klinik Floridsdorf
19 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endobronchial Coils in people with Emphysema, run by Boston Scientific Corporation at 19 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Germany, France, Austria, Italy, Netherlands and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in FEV1 at 6 Months (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03360396, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2023.