Pilot Study of the Spiration IBV™ System

June 14, 2011 updated by: Spiration, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory Health Care
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Lahey Clinic
    • New York
      • Long Island, New York, United States, 11030
        • North Shore - Long Island Jewish Health System
      • New York City, New York, United States, 10032
        • Columbia University Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27110
        • Duke University Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health System
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
The secondary endpoint is to estimate the effectiveness achieved after 1 and 3 months of use.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spiration, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

September 1, 2005

First Submitted That Met QC Criteria

September 1, 2005

First Posted (Estimate)

September 5, 2005

Study Record Updates

Last Update Posted (Estimate)

June 16, 2011

Last Update Submitted That Met QC Criteria

June 14, 2011

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPR-0003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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