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European Multi-Center Post Market Study of the IBV Valve System

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Spiration, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Spiration, Inc.
ClinicalTrials.gov Identifier:
NCT00880724
First received: April 10, 2009
Last updated: June 25, 2009
Last verified: June 2009
  Purpose

The objective of this randomized, blinded, multicenter, controlled study is to compare the performance of the IBV Valve System (treatment group) to a control group receiving a sham bronchoscopy procedure without valve placement.


Condition Intervention
Chronic Obstructive Pulmonary Disease
Device: IBV Valve

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: European Post Market Study: A Prospective, Randomized, Controlled, Multicenter Study to Evaluate the Performance 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:
  • The difference between the response rates of the treatment and control groups. [ Time Frame: 3-months post randomization ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: March 2007
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Medical management Device: IBV Valve
Placement of IBV Valve in the airways of treatment subjects. Bronchoscopic procedure in control group.
Other Names:
  • BLVR
  • Endoscopic Volume Reduction
  • Endobronchial Valve

Detailed Description:

The IBV Valve System (Spiration Inc. Redmond, WA) has CE Mark approval for the treatment of diseased and damaged lung. The devices are one-way valves that can be placed in the airways via flexible bronchoscopy limiting airflow distally. For the treatment of emphysema, valves are placed in airways communicating to the most diseased areas of lung tissue to re-direct airflow to less diseased areas. A multicenter, blinded and randomized study of these valves is being conducted in 7 centers in 6 European countries. The study is evaluating the effectiveness of this therapy for the treatment of upper lobe predominant emphysema in patients with severe to very severe emphysema (GOLD classification 3 to 4) that despite best medical management continue having poor quality of life, severe symptoms and physical limitations. The primary endpoints are to measure and compare responses using the St. George's Respiratory Questionnaire and lung volume changes as measured by CT-scans. Consented patients that meet the strict inclusion criteria have a bronchoscopic procedure and are randomized into treatment or control (no valves) groups. After the procedure, all patients stay blinded to their group assignment and have follow-up evaluations at 1 and 3 months. After the 3-month evaluation, each patient is un-blinded. The treatment group is then scheduled for an additional follow-up at 6 months and the control group is offered valve treatment (rollover) and evaluated approximately 3 months later.

  Eligibility

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

Inclusion Criteria:

  • Between 40 and 74 years of age
  • Predominantly upper lobe emphysema and severe dyspnea
  • Satisfies the criteria of the ATS/ERS Guidelines for Management of Stable COPD
  • Physical ability to participate in the study by performing a 6-minute walk distance of > 140m
  • No cigarette smoking for 4 months and willing to abstain throughout the study
  • Severe airflow obstruction defined by FEV1 45% of predicted
  • Severe hyperinflation defined by: TLC > 100% of predicted and RV > 150% of predicted

Exclusion Criteria:

  • Between 70 and 74 years of age and an FEV1 or DLCO < 20% of predicted
  • Severe gas exchange abnormalities
  • Major medical disease that will limit evaluation, participation or follow-up
  • Active asthma component to their disease
  • Giant bulla (> 1/3 volume of lung)
  • Severe pulmonary hypertension
  • Requirement for > 6L02 to keep saturation > 90% with exercise
  • Evidence of systemic disease or neoplasia expected to compromise survival during the 6-month study period
  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: NCT00880724

Locations
Austria
Landeskrankenhaus
Innsbruck, Austria
Belgium
CHU Saint Pierre
Bruxelles, Belgium
Germany
Medizinische Hochschule Hannover
Hannover, Germany
Italy
Spedali Civili di Brescia
Brescia, Italy
Spain
Bellvitge Hospital
Barcelona, Spain
Clinica Universitaria de Navarra
Pamplona, Spain
United Kingdom
Royal Preston Hospital/Lancashire Teaching Hospitals
Preston, United Kingdom
Sponsors and Collaborators
Spiration, Inc.
  More Information

Additional Information:
No publications provided by Spiration, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: H. Xavier Gonzalez, M.D., Spiration, Inc.
ClinicalTrials.gov Identifier: NCT00880724     History of Changes
Other Study ID Numbers: CPR-01576 AD
Study First Received: April 10, 2009
Last Updated: June 25, 2009
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Spiration, Inc.:
COPD
Emphysema
Bronchoscopic Treatment
Interventional Bronchoscopy

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

ClinicalTrials.gov processed this record on November 20, 2014