Pilot Study of the Spiration IBV™ System

This study has been completed.
Sponsor:
Information provided by:
Spiration, Inc.
ClinicalTrials.gov Identifier:
NCT00145548
First received: September 1, 2005
Last updated: June 14, 2011
Last verified: May 2007
  Purpose

The Spiration Intra-Bronchial Valve is intended for use as a minimally invasive treatment for severe emphysema, using standard bronchoscopy. The valve is designed to limit airflow to a selected portion of the lung, producing a reduction in lung volume, which may improve pulmonary function in patients with emphysema.


Condition Intervention Phase
Emphysema
Device: Intra Bronchial Valve
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of the Spiration IBV™ System

Resource links provided by NLM:


Further study details as provided by Spiration, Inc.:

Primary Outcome Measures:
  • The primary endpoint of this study is to evaluate the safety of the device, during deployment and short-term implantation for a period of up to 3 months.

Secondary Outcome Measures:
  • The secondary endpoint is to estimate the effectiveness achieved after 1 and 3 months of use.

Enrollment: 91
Study Start Date: December 2003
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Detailed Description:

This pilot study is an open enrollment, prospective study with each subject serving as their own control. The sponsor may attempt to include the data from this study in the statistical analysis of the pivotal study. This proposal shall be evaluated at the conclusion of the pilot study.

PATIENT POPULATION Patients with severe emphysema are eligible to be screened for enrollment in this study. In this initial pilot study, eligible subjects will have severe, heterogeneous, predominantly upper lobe emphysema, as defined by the American Thoracic Society (ATS) 1 and the NETT Research Group.2

These subjects also will be patients who have been screened as potential candidates for LVRS, but who have been excluded from surgical treatment due to a failure to satisfy the inclusion and exclusion criteria established by the NETT Research Group for LVRS.2 Patients also will be able to tolerate a flexible bronchoscopy procedure.

Patients who have been screened and accepted for a lung transplant procedure or LVRS, and are currently registered or scheduled for such a procedure, are not eligible for enrollment in this pilot study.

Patients with an FEV1 < 20% predicted and either homogeneous emphysema or DLCO < 20% will be excluded from enrollment in this pilot study.3

Patients will be screened and enrolled until up to 115 subjects have undergone treatment with the IBV System. Up to 15 clinical centers will be selected to enroll and treat subjects.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and Female subjects at least 18 years of age.
  • Subject has severe, heterogeneous, predominantly upper lobe emphysema.
  • Subject has ability to meet goals of, or currently satisfies goals of, a comprehensive pulmonary rehabilitation program.
  • Subject has satisfied requirement for post-rehabilitation 6-minute walk of ≥ 140 m 6 and is able to complete 3 min unloaded pedaling in exercise tolerance test.
  • Subject has abstained from cigarette smoking for 4 months, as confirmed by urine or serum cotinine test.
  • Pulmonary function testing results demonstrate:

    • FEV1 ≤ 45% predicted (≥ 15% predicted if age ≥ 70 years)
    • TLC ≥ 100% predicted
    • RV ≥ 150% predicted
  • Arterial blood gas level indicates:

    • PCO2 ≤ 50 mm Hg
    • PO2 ≥ 45 mm Hg on room air (Denver criterion: PO2 ≥ 30 mm Hg)
  • Subject has no co-existing major medical problems that would significantly increase the risk of the bronchoscopy procedure and is classified as ASA Class P4 or lower.
  • If female, subject is not pregnant by a negative HCG pregnancy test within 7 days prior to the procedure.
  • Subject has willingness to undertake the risk and morbidity associated with the required bronchoscopic procedures.
  • Subject has willingness to participate in the study and complete the required follow-up visits.
  • Subject has ability to provide informed consent.
  • Subject has provided consent for treatment under this protocol and has granted access to relevant medical records to the sponsor, the Principal Investigator, the institution, the IRB and the FDA pertaining to their current lung disease condition, evaluation process, and the surgical procedure.

Exclusion Criteria:

  • Patients with FEV1< 20% predicted and either homogeneous emphysema or DLCO < 20%. 3
  • Subject is unable to provide informed consent.
  • Subject is not an appropriate candidate for, or unable to tolerate, flexible bronchoscopy procedures.
  • Subject has dysrhythmia that might pose a risk during exercise or training.
  • Subject has resting bradycardia (< 50 beats/min); frequent multifocal PVCs; complex ventricular arrhythmia; sustained SVT.
  • Subject has history of exercise-related syncope.
  • Subject has uncontrolled hypertension (systolic, > 200 mm; diastolic > 110 mm).
  • Subject has history of recurrent infections with clinically significant sputum production
  • Subject has known, active asthma, chronic bronchitis or clinically significant bronchiectasis.
  • Subject has giant bulla (> 1/3 volume of lung).
  • Subject has pulmonary hypertension: peak systolic PPA, ≥ 45 mm Hg (Denver criterion: ≥ 50 mm Hg) or mean PPA, ≥ 35 mm Hg (Denver criterion: ≥ 38 mm Hg). (Right heart catheter is required to rule out pulmonary hypertension if peak systolic PPA on echocardiogram is ≥ 45 mm Hg.)
  • Subject has requirement for > 6 L O2 to keep saturation ≥ 90% with exercise.
  • Subject has evidence of systemic disease or neoplasia expected to compromise survival during the 1-year study period.
  • Subject demonstrates 6MWT distance ≤ 140 m after rehabilitation.
  • Subject has any disease or condition that interferes with completion of initial or follow-up assessments.
  • Subject has demonstrated unwillingness or inability to complete screening or baseline data collection procedures.
  • Subject has only the homogeneous emphysema pattern.
  • Subject is classified as ASA Class greater than P4 7 including presence of co-morbidity that could significantly increase the risk of a standard bronchoscopy procedure.
  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: NCT00145548

Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35294
United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Georgia
Emory Health Care
Atlanta, Georgia, United States, 30322
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Lahey Clinic
Burlington, Massachusetts, United States, 01805
United States, New York
North Shore - Long Island Jewish Health System
Long Island, New York, United States, 11030
Columbia University Medical Center
New York City, New York, United States, 10032
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27110
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
The Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195
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):
ClinicalTrials.gov Identifier: NCT00145548     History of Changes
Other Study ID Numbers: CPR-0003
Study First Received: September 1, 2005
Last Updated: June 14, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Spiration, Inc.:
COPD

ClinicalTrials.gov processed this record on September 18, 2014