Clinical Trial to Evaluate the Safety and Effectiveness of the IBV® Valve System for the Treatment of Severe Emphysema

COPD Clinical Trial

— IBV®Valve  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00475007
• Other study ID #: CPR-01377
• Status: Completed
• Phase: N/A
• First received: May 16, 2007
• Last updated: April 16, 2018
• Start date: September 2007
• Est. completion date: August 2017

Study information

• Verified date: November 2017
• Source: Spiration, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 277
• Est. completion date: August 2017
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• COPD
• Emphysema
• Pulmonary Emphysema

Intervention

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.

Locations

Country	Name	City	State
United States	Akron General Medical Center	Akron	Ohio
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	Emory HealthCare	Atlanta	Georgia
United States	Pulmonary and Critical Care Associates of Baltimore	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of Virginia Health System	Charlottesville	Virginia
United States	University of Chicago	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	National Jewish Medical & Research Center	Denver	Colorado
United States	Alexian Brothers Hospital Network	Elk Grove Village	Illinois
United States	University of Florida	Gainesville	Florida
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Kaiser Permanente Medical Center	Los Angeles	California
United States	University of California Los Angeles (UCLA)	Los Angeles	California
United States	University of Louisville	Louisville	Kentucky
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Mission Internal Medicine Group	Mission Viejo	California
United States	Columbia University Medical Center	New York	New York
United States	Mount Sinai School of Medicine	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Kaiser Permanente Northwest	Portland	Oregon
United States	Rhode Island Hospital	Providence	Rhode Island
United States	University of California Davis Medical Center	Sacramento	California
United States	Health Partners Research Foundation/Regions Hospital	Saint Paul	Minnesota
United States	University of Utah	Salt Lake City	Utah
United States	University of Texas Health Science Center	San Antonio	Texas
United States	University of California San Diego	San Diego	California
United States	Sarasota Memorial Hospital	Sarasota	Florida
United States	University of Washington	Seattle	Washington
United States	Southern Illinois University School of Medicine	Springfield	Illinois
United States	Pulmonary and Allergy Associates	Summit	New Jersey
United States	Franciscan Research Center	Tacoma	Washington
United States	Scott and White Memorial Hospital	Temple	Texas
United States	Oklahoma State University	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Spiration, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		6 months
Secondary	The difference between average 6 minute walk test results for treatment & control groups.		6 months