Trial record 1 of 1 for:    NCT00475007
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Clinical Trial to Evaluate the Safety and Effectiveness of the IBV® Valve System for the Treatment of Severe Emphysema (IBV®Valve)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Spiration, Inc.
ClinicalTrials.gov Identifier:
NCT00475007
First received: May 16, 2007
Last updated: February 26, 2013
Last verified: February 2013
  Purpose

This trial is for men and women between the ages of 40 and 74 who have a confirmed diagnosis of emphysema. The objective of the trial is to determine the safety and effectiveness of the IBV Valve at redirecting airflow from diseased portions of the lung to healthier areas to achieve improvement in disease-related health status.


Condition Intervention Phase
Emphysema
COPD
Device: IBV® Valve System
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled Multicenter Clinical Trial to Evaluate the Safety and Effectiveness of the IBV® Valve System for the Treatment of Severe Emphysema

Resource links provided by NLM:


Further study details as provided by Spiration, Inc.:

Primary Outcome Measures:
  • Difference between responder rates of the treatment & control groups, responders defined as subjects with clinically meaningful improvements in disease-related health status (SGRQ) & regional lung volume changes as measured by quantitative CT scan. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The difference between average 6 minute walk test results for treatment & control groups. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: September 2007
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
The experimental group will have an investigational medical device implanted in their lungs with an instrument known as a bronchoscope. This procedure is done without an incision
Device: IBV® Valve System
The IBV Valve is a small, umbrella shaped device designed to redirect airflow to healthier areas of the lungs. It is implanted without incisions using a bronchoscope.
Sham Comparator: 2
The sham comparator group will be tested, treated and followed in an identical manner as the experimental group, except that no valves will be placed during the diagnostic bronchoscopy, the sham procedure.
Device: IBV® Valve System
The IBV Valve is a small, umbrella shaped device designed to redirect airflow to healthier areas of the lungs. It is implanted without incisions using a bronchoscope.

Detailed Description:

The IBV Valve Trial is a multi-center clinical trial evaluating the IBV Valve System, a non-surgical treatment for patients with emphysema. The IBV Valve System does not require traditional surgery or surgical incisions. The valves are placed during a bronchoscopic procedure. The IBV Valve System is designed to redirect airflow from diseased portions of the lung to healthier areas to achieve improvement in disease-related health status. Although the valves are intended to be permanent, they are designed to be removed if necessary.

The IBV Valve Trial is a randomized, blinded trial. This means that participants are divided into two groups but do not know to which group they have been assigned.

The IBV Valve Treatment Group receives valves, and the Control Group does not. A random selection process decides the group assignments (participants will not be able to choose their group). In the trial, everyone will have a 50 percent chance (similar to a coin toss) to be assigned to one group or the other.

All Participants in this Clinical Trial will:

Receive a diagnostic bronchoscopy that will allow an expert in lung health to evaluate their lungs.

Be under the care of a highly qualified lung doctor for the entire time they are in the trial, regardless of whether they are in the Treatment Group or the Control Group.

Receive regular periodic check-ups and health assessments throughout the 6 month trial period.

The procedure, all testing, and doctor visits are provided at no cost to participants of both the IBV Valve Treatment Group and the Control Group.

At the completion of their 6-month visit, participants will be told if they were assigned to the Treatment Group or the Control Group. If participants were assigned to the group that did not receive valves (the Control Group), they will be given the option to be re-evaluated by the clinical trial doctor, to determine if they can have valve treatment.

  Eligibility

Ages Eligible for Study:   40 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Candidates have mostly upper lobe, severe emphysema.
  • Must be able to participate in standard exercise testing.
  • Willing to abstain from cigarette smoking for 4 months prior and during the entire trial.
  • Willing to participate in a randomized, blinded study and complete the required follow-up visits during the study period.
  • Willing to participate in multiple visits to a medical center for health assessment tests.
  • Willing to have a minimum of one overnight stay in the hospital.

Exclusion Criteria:

  • Evidence of another co-existing major medical disease.
  • Unable to tolerate, flexible bronchoscopy procedures.
  • Active asthma, chronic bronchitis.
  • Diffuse emphysema pattern, alpha 1-antitrypsin deficiency.
  • Has had prior lung volume reduction surgery.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00475007

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
University of California Los Angeles (UCLA)
Los Angeles, California, United States, 90095
Kaiser Permanente Medical Center
Los Angeles, California, United States, 90027
University of California Davis Medical Center
Sacramento, California, United States, 95817
University of California San Diego
San Diego, California, United States, 92103
United States, Colorado
National Jewish Medical & Research Center
Denver, Colorado, United States, 80206
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sarasota Memorial Hospital
Sarasota, Florida, United States, 34239
United States, Georgia
Emory HealthCare
Atlanta, Georgia, United States, 30322
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Alexian Brothers Hospital Network
Elk Grove Village, Illinois, United States, 60007
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62794
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Maryland
Pulmonary and Critical Care Associates of Baltimore
Baltimore, Maryland, United States, 21237
United States, Minnesota
Health Partners Research Foundation/Regions Hospital
St. Paul, Minnesota, United States, 55101
United States, New Jersey
Pulmonary and Allergy Associates
Summit, New Jersey, United States, 07901
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Columbia University Medical Center
New York, New York, United States, 10032
United States, Ohio
Akron General Medical Center
Akron, Ohio, United States, 44307
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Oklahoma
Oklahoma State University
Tulsa, Oklahoma, United States, 74127
United States, Oregon
Kaiser Permanente Northwest
Portland, Oregon, United States, 97227
United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18103
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
University of Texas Health Science Center
San Antonio, Texas, United States, 78258
Scott and White Memorial Hospital
Temple, Texas, United States, 76508
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84148
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Franciscan Research Center
Tacoma, Washington, United States, 98405
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Spiration, Inc.
  More Information

No publications provided

Responsible Party: Spiration, Inc.
ClinicalTrials.gov Identifier: NCT00475007     History of Changes
Other Study ID Numbers: CPR-01377
Study First Received: May 16, 2007
Last Updated: February 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Spiration, Inc.:
Emphysema
IBV® Valve
COPD
Shortness of Breath
Spiration

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 16, 2014