EmphysemaCROSSOVERNCT02059057
LVRC IDE Crossover Study (Crossover From IDE Trial CLN0009)
A study testing LVRC System in people with Emphysema, run by Boston Scientific Corporation at 25 sites in 5 countries.
Trial summary
Crossover study for patients who were randomized to the Control Group in CLN0009 (NCT01608490). Read more about this study
- Who is it for?
- Ages 36 years and older
- Conditions the study is for
- Emphysema
- What is being tested?
- LVRC System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 25 sitesin 5 countries
- Study dates
- Dec 2013to 26 Jul 2019
- 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 36 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject was enrolled as a Control Subject in and completed all required study assessments through the 12 month visit for the Lung Volume Reduction Coil Treatment in Patients with Emphysema (RENEW) Study, CLN0009.
- Subject has post-bronchodilator FEV1 ≤45% predicted.
- Subject has residual volume (RV) ≥175% predicted.
- 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 read, understood and signed the Informed Consent form.
- Subject has received Pneumococcal and Influenza vaccinations consistent with local recommendations and/or policy.
Who cannot join
- Subject has severe homogeneous emphysema as determined by the 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 >20% (or, for subjects with pre-bronchodilator FEV1 below 1 L, a change of > 200 mL) post-bronchodilator, unless investigator can confirm by other means that subject does not have asthma.
- Subject has DLCO <20% of predicted.
- Subject has severe gas exchange abnormalities as defined by:
- PaCO2 >55 mm Hg PaO2 <45 mm Hg on room air (High altitude criterion: PaO2 <30 mm Hg)
Show all 24Show fewer
- Subject has a history of recurrent clinically significant respiratory infections, defined as 3 hospitalizations for respiratory infection during the year prior to enrollment.
- Subject has severe pulmonary hypertension. If pulmonary hypertension is present, "severe" is defined by right ventricular systolic pressure >50 mm Hg via right heart catheterization and/or echocardiogram.
- Subject has an inability to walk >140 meters (150 yards) 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, LVR devices or other devices to treat COPD in either lung.
- Subject has been involved in pulmonary drug or device studies within 30 days prior to this study, with the exception of the RENEW Study.
- Subject is taking >20 mg 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 seven (7) days prior to procedure.
- Subject has a sensitivity or allergy to nitinol (nickel-titanium) or its constituent metals.
- Subject has a known sensitivity to drugs required to perform bronchoscopy.
- Subject has been diagnosed with alpha-1 antitrypsin deficiency (AATD).
- 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.
- -
Trial locations and contacts
25 sites in 5 countries.
25 sites in 5 countries
United States20 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
University of Alabama Lung Health Center
Birmingham, Alabama, 35294
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Medical University of South Carolina
Charleston, South Carolina, 29425-6300
Northwestern University
Chicago, Illinois, 60611
The Cleveland Clinic
Cleveland, Ohio, 44195
Duke University Medical Center
Durham, North Carolina, 27710
University of Florida
Gainesville, Florida, 32610
Pulmonary, Critical Care & Sleep Medicine Consultants,PCCS/St. Luke's Episcopal Hospital
Houston, Texas, 77030
Cedars Sinai Medical Center
Los Angeles, California, 90048
University of Wisconsin School of Medicine & Public Health
Madison, Wisconsin, 53792
El Camino Hospital/Palo Alto Medical Foundation
Mountain View, California, 94040
Yale University School of Medicine - Yale New Haven Hospital
New Haven, Connecticut, 06510
New York Presbyterian Columbia University Medical Center
New York, New York, 10032
Illinois Lung and Critical Care Institute
Peoria, Illinois, 61606
Temple
Philadelphia, Pennsylvania, 19140
Emphysema COPD Research Center, University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Mayo Clinic
Rochester, Minnesota, 55905
University of Texas Health Sciences Center at San Antonio
San Antonio, Texas, 78229-3900
Franciscan Research Center
Tacoma, Washington, 98405
France2 sites
Centre Hospitalier Universitaire de Nice
Nice, CS 51069
CHU de Reims - Hopital Maison Blanche
Reims, 51092
Canada1 site
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
Québec
Netherlands1 site
University Medical Center Groningen
Groningen, 3150-3610536
United Kingdom1 site
Royal Brompton Hospital & Chelsea Westminster
London, SW3 6NP
About this study
Official title: Crossover From IDE Trial CLN0009, Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study, IDE G110066
Crossover study for patients who were randomized to the Control Group in CLN0009 (NCT01608490).
Read the detailed description
Provide LVRC procedure to qualifying subjects who were enrolled as Control Subjects in and completed the Lung Volume Reduction Coil Treatment in Patients with Emphysema (RENEW) Study, CLN0009, and obtain safety and effectiveness data on these patients.
- Conditions
- Emphysema
- Being tested
- LVRC System
- Medical subject headings
- Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LVRC SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| LVRC System | Experimental | Not described Receives: Device: LVRC System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Six Minute Walk Test (6MWT)
Mean absolute change from baseline to12 months. The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.
Measured: Change in Baseline to 12 months
Secondary outcomes (3)
Mean Percent Change in Forced Expiratory Volume in One Second (FEV1)
The forced expiratory volume in one second (FEV1) measurement shows the amount of air a person can forcefully exhale in one second. Typically, lower FEV1 scores show more severe stages of lung disease. A positive change in FEV1 indicates improvement in lung function.
Measured: Change in Baseline to 12 months
Mean Change in Residual Volume (RV)
Residual volume is the amount of air that remains in a person's lungs after fully exhaling. A decrease in residual volume indicates improvement in patients with higher residual volume measures.
Measured: Change in Baseline to 12 months
Mean Change in St. Georges Respiratory Questionnaire (SGRQ)
Measure Description: The SGRQ is designed to measure health impairment in patients with asthma and COPD.
It consists of 50 items and has two parts: Part I (Symptoms): several scales; Part II (Activity and Impacts): dichotomous (true/false) except last question (4-point Likert scale)
Scores range from 0 to 100, with higher scores indicating more limitations.
A negative change in score indicates improvement, with a mean change of 4 points being the minimal important difference.
Measured: Change in Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study startDec 2013
- Primary completionJun 2017
- Study completion26 Jul 2019
Why it stopped: FDA approval of supplementation to IDE/protocol amendment to terminate subject long term follow up
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PneumRx, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02059057
- Sponsor's protocol ID
- CLN0016
- Acronym
- CROSSOVER
- Status last verified
- Jul 2021
- First submitted
- 6 Feb 2014
- Last updated
- 19 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crossover From IDE Trial CLN0009, Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study, IDE G110066
- ClinicalTrials.gov ID
- NCT02059057
- Acronym / sponsor ID
- CROSSOVER / CLN0016
- Conditions
- Emphysema
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: FDA approval of supplementation to IDE/protocol amendment to terminate subject long term follow up
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Collaborators
- PneumRx, Inc.
- Study start
- Dec 2013 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- 26 Jul 2019 (actual)
- First posted
- 11 Feb 2014 (estimated)
- Results
- Posted 25 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Crossover study for patients who were randomized to the Control Group in CLN0009 (NCT01608490).
Detailed description
Provide LVRC procedure to qualifying subjects who were enrolled as Control Subjects in and completed the Lung Volume Reduction Coil Treatment in Patients with Emphysema (RENEW) Study, CLN0009, and obtain safety and effectiveness data on these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LVRC System | Experimental | Device: LVRC System |
Who may qualify
- Ages
- 36 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject was enrolled as a Control Subject in and completed all required study assessments through the 12 month visit for the Lung Volume Reduction Coil Treatment in Patients with Emphysema (RENEW) Study, CLN0009.
- Subject has post-bronchodilator FEV1 ≤45% predicted.
- Subject has residual volume (RV) ≥175% predicted.
- 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 read, understood and signed the Informed Consent form.
Key exclusion criteria (24 listed)
- Subject has severe homogeneous emphysema as determined by the 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 >20% (or, for subjects with pre-bronchodilator FEV1 below 1 L, a change of > 200 mL) post-bronchodilator, unless investigator can confirm by other means that subject does not have asthma.
- Subject has DLCO <20% of predicted.
- Subject has severe gas exchange abnormalities as defined by:
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 |
|---|---|---|
| LVRC System | Device | LVRC System |
Primary outcome
Mean Change in Six Minute Walk Test (6MWT)
Time frame: Change in Baseline to 12 months
Mean absolute change from baseline to12 months. The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.
3 secondary outcomes
Mean Percent Change in Forced Expiratory Volume in One Second (FEV1)
Time frame: Change in Baseline to 12 months
Mean Change in Residual Volume (RV)
Time frame: Change in Baseline to 12 months
Mean Change in St. Georges Respiratory Questionnaire (SGRQ)
Time frame: Change in Baseline to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Emphysema
RecruitingEarly Phase 1
Xenon MRI to Evaluate Changes to Lung Function Following Bronchoscopic Treatment of Air Trapping in Emphysema
Air Trapping, Emphysema
RecruitingPhase 3
A Non-inferiority Pharmacokinetic and Safety/Tolerability Study of Two Different Doses of Weekly SC Alpha1-PI 15% Compared With Corresponding Standard IV Alpha1-PI in Participants With Alpha1-Antitrypsin Deficiency (AATD)
Alpha 1 Antitrypsin Deficiency
RecruitingObservational study
Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies
Chronic Obstructive Pulmonary Disease (COPD), Smoking
RecruitingPhase 1
A Study of AIR-001 in Adults With Alpha-1 Antitrypsin Deficiency (AATD)
Alpha 1 Antitrypsin Deficiency
Active, not recruitingObservational study
Examining the Genetic Factors That May Cause Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive, Emphysema
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.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LVRC System in people with Emphysema, run by Boston Scientific Corporation at 25 sites in 5 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 6 inclusion and 24 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: stopped early, as of the sponsor's last update on 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, France, Canada, Netherlands, United Kingdom. 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 25 Sep 2018). 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?
Mean Change in Six Minute Walk Test (6MWT) (time frame: Change in Baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jul 2021; AzTrials last refreshed its copy on 29 Oct 2026.