- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02059057
LVRC IDE Crossover Study (Crossover From IDE Trial CLN0009) (CROSSOVER)
Crossover From IDE Trial CLN0009, Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study, IDE G110066
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Quebec, Canada
- Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
-
-
-
-
-
Nice, France, CS 51069
- Centre Hospitalier Universitaire de Nice
-
Reims, France, 51092
- CHU de Reims - Hôpital Maison Blanche
-
-
-
-
-
Groningen, Netherlands, 3150-3610536
- University Medical Center Groningen
-
-
-
-
-
London, United Kingdom, SW3 6NP
- Royal Brompton Hospital & Chelsea Westminster
-
-
-
-
Alabama
-
Birmingham, Alabama, United States, 35294
- University of Alabama Lung Health Center
-
-
California
-
Los Angeles, California, United States, 90048
- Cedars Sinai Medical Center
-
Mountain View, California, United States, 94040
- El Camino Hospital/Palo Alto Medical Foundation
-
-
Connecticut
-
New Haven, Connecticut, United States, 06510
- Yale University School of Medicine - Yale New Haven Hospital
-
-
Florida
-
Gainesville, Florida, United States, 32610
- University of Florida
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern University
-
Peoria, Illinois, United States, 61606
- Illinois Lung and Critical Care Institute
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan Health System
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
-
New York
-
New York, New York, United States, 10032
- New York Presbyterian Columbia University Medical Center
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Duke University Medical Center
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- The Cleveland Clinic
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19140
- Temple
-
Pittsburgh, Pennsylvania, United States, 15213
- Emphysema COPD Research Center, University of Pittsburgh
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425-6300
- Medical University of South Carolina
-
-
Texas
-
Houston, Texas, United States, 77030
- Pulmonary, Critical Care & Sleep Medicine Consultants,PCCS/St. Luke's Episcopal Hospital
-
San Antonio, Texas, United States, 78229-3900
- University of Texas Health Sciences Center at San Antonio
-
-
Washington
-
Tacoma, Washington, United States, 98405
- Franciscan Research Center
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53792
- University of Wisconsin School of Medicine & Public Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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)
- 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.
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: LVRC System
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Change in Baseline to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Percent Change in Forced Expiratory Volume in One Second (FEV1)
Time Frame: Change in Baseline to 12 months
|
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.
|
Change in Baseline to 12 months
|
Mean Change in Residual Volume (RV)
Time Frame: Change in Baseline to 12 months
|
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.
|
Change in Baseline to 12 months
|
Mean Change in St. Georges Respiratory Questionnaire (SGRQ)
Time Frame: Change in Baseline to 12 months
|
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. |
Change in Baseline to 12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLN0016
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Emphysema
-
Pulmonx CorporationRecruitingEmphysema or COPD | Emphysema, PulmonarySpain, Germany, Italy, Australia
-
Pulmonx CorporationActive, not recruiting
-
Heidelberg UniversityUnknown
-
Royal Brompton & Harefield NHS Foundation TrustCompletedHeterogeneous EmphysemaUnited Kingdom
-
Aeris TherapeuticsCompleted
-
Pulmonx CorporationCompleted
-
University Medical Center GroningenCompletedEmphysema or COPDNetherlands
-
University Medical Center GroningenRecruitingEmphysema or COPDNetherlands
-
Aeris TherapeuticsCompleted
-
Rabin Medical CenterUnknownPatients With Advanced Homogeneous EmphysemaIsrael
Clinical Trials on LVRC System
-
Boston Scientific CorporationPneumRx, Inc.Terminated
-
Boston Scientific CorporationPneumRx, Inc.TerminatedEmphysemaUnited Kingdom, Spain, Germany, Switzerland, Austria, Denmark
-
Boston Scientific CorporationPneumRx, Inc.Completed
-
University Hospital, ToulouseTerminated
-
Boston Scientific CorporationPneumRx, Inc.Completed
-
Boston Scientific CorporationPneumRx, Inc.CompletedEmphysemaNetherlands, Germany, France
-
Boston Scientific CorporationPneumRx, Inc.CompletedEmphysemaGermany, Netherlands
-
ResMedCompleted
-
Federal University of São PauloCompletedAdverse Reaction to Systemic AgentsBrazil