Trial record 1 of 1 for:    NCT00475007
Previous Study | Return to List | Next Study

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

May 16, 2007
February 26, 2013
September 2007
October 2015   (final data collection date for primary outcome measure)
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 ]
  • Difference between responder rates of treatment & control groups in disease related health status measured by:
  • SGRQ total score change of greater than or equal to 4 points and
  • CT scan regional lung volume changes at 6 months of greater than or equal to 10% increase in the NUL and any reduction in UL
  • Difference between treatment & control groups in composite of all SAEs
Complete list of historical versions of study NCT00475007 on ClinicalTrials.gov Archive Site
The difference between average 6 minute walk test results for treatment & control groups. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Rate of composite procedure-related serious adverse events from pooled treatment & control
  • Rate of composite non-procedure related serious adverse events in treatment subtracted by procedure related complications will be compared to similar serious adverse events relate in control
  • Difference between average 6 minute walk test results for treatment & control at 6 months
Not Provided
Not Provided
 
Clinical Trial to Evaluate the Safety and Effectiveness of the IBV® Valve System for the Treatment of Severe Emphysema
A Prospective, Randomized, Controlled Multicenter Clinical Trial to Evaluate the Safety and Effectiveness of the IBV® Valve System for the Treatment of Severe Emphysema

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Emphysema
  • COPD
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.
  • 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
    Intervention: Device: IBV® Valve System
  • 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.
    Intervention: Device: IBV® Valve System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
300
October 2015
October 2015   (final data collection date for primary outcome measure)

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.
Both
40 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00475007
CPR-01377
Yes
Spiration, Inc.
Spiration, Inc.
Not Provided
Not Provided
Spiration, Inc.
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP